Glickman Urological & Kidney Institute

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108374_CCFBCH_17OUT426_acg.indd 1-3 8/31/17 3:02 PM Measuring Outcomes Promotes Quality Improvement

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108374_CCFBCH_17OUT426_acg.indd 4-6 8/31/17 3:02 PM Measuring and understanding outcomes of medical treatments promotes quality improvement. Cleveland Clinic has created a series of Outcomes books similar to this one for its clinical institutes. Designed for a physician audience, the Outcomes books contain a summary of many of our surgical and medical treatments, with a focus on outcomes data and a review of new technologies and innovations.

The Outcomes books are not a comprehensive analysis of all treatments provided at Cleveland Clinic, and omission of a particular treatment does not necessarily mean we do not offer that treatment. When there are no recognized clinical outcome measures for a specific treatment, we may report process measures associated with improved outcomes. When process measures are unavailable, we may report volume measures; a relationship has been demonstrated between volume and improved outcomes for many treatments, particularly those involving surgical and procedural techniques.

In addition to these institute-based books of clinical outcomes, Cleveland Clinic supports transparent public reporting of healthcare quality data. The following reports are available to the public:

• Joint Commission Performance Measurement Initiative (qualitycheck.org) • Centers for Medicare and Medicaid Services (CMS) Hospital Compare (medicare.gov/hospitalcompare), and Physician Compare (medicare.gov/PhysicianCompare) • Cleveland Clinic Quality Performance Report (clevelandclinic.org/QPR)

Our commitment to transparent reporting of accurate, timely information about patient care reflects Cleveland Clinic’s culture of continuous improvement and may help referring physicians make informed decisions.

We hope you find these data valuable, and we invite your feedback. Please send your comments and questions via email to: [email protected].

To view all of our Outcomes books, please visit clevelandclinic.org/outcomes.

108374_CCFBCH_17OUT426_acg.indd 1 8/31/17 3:14 PM Dear Colleague:

Welcome to this 2016 Cleveland Clinic Outcomes book. Every year, we publish Outcomes books for 14 clinical institutes with multiple specialty services. These publications are unique in healthcare. Each one provides an overview of medical or surgical trends, innovations, and clinical data for a particular specialty over the past year. We are pleased to make this information available.

Cleveland Clinic uses data to manage outcomes across the full continuum of care. Our unique organizational structure contributes to our success. Patient services at Cleveland Clinic are delivered through institutes, and each institute is based on a single disease or organ system. Institutes combine medical and surgical services, along with research and education, under unified leadership. Institutes define quality benchmarks for their specialty services and report on longitudinal progress.

All Cleveland Clinic Outcomes books are available in print and online. Additional data are available through our online Quality Performance Reports (clevelandclinic.org/QPR). The site offers process measure, outcome measure, and patient experience data in advance of national and state public reporting sites.

Our practice of releasing annual Outcomes books has become increasingly relevant as healthcare transforms from a volume-based to a value-based system. We appreciate your interest and hope you find this information useful and informative.

Sincerely,

Delos M. Cosgrove, MD CEO and President

2 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 2 8/31/17 3:14 PM what’s inside

Chairman’s Letter 04

Institute Overview 05

Quality and Outcomes Measures

In-Hospital Mortality 07

Length of Stay 08

Nephrology

Chronic Kidney Disease 09

Hypertension 16

ICU Nephrology 17

Transplantation 19

Urology

Bladder/Voiding Dysfunction 21

Kidney 22

Male Fertility 43

Prostate 45

Urethra/Reconstruction 76

Institute Quality Improvement Initiatives 79

Surgical Quality Improvement 86

Institute Patient Experience 88

Cleveland Clinic — Implementing Value-Based Care 90

Innovations 98

Contact Information 102

About Cleveland Clinic 104

Resources 106

Glickman Urological & Kidney Institute 3

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ChairmanChairman’s Letter Letter

Dear Colleagues, I appreciate your interest in Glickman Urological & Kidney Institute and taking the time to glance through our 2016 outcomes report. Each year we collect and analyze vital data, not just to satisfy our curiosity, but to ensure that we are indeed improving the quality of care we provide and quality of life for our patients. We remain devoted to excellence and innovation in all aspects of our work -- clinical care, research, and education. We believe our consistently high rankings by U.S. News & World Report (No. 1 or No. 2 in the nation since 2012) reflect this dedication and hard work. Among our accomplishments in 2016: • Developed a nomogram to predict the likelihood of kidney stone passage and help guide follow-up and intervention • Established an oxidation-reduction potential assay using a novel galvanostatic technology as an effective method for measuring oxidative stress in semen and distinguishing normal men from those with male factor infertility • Developed a technique to use a buccal mucosal graft in a salvage robotic laparoscopic pyeloplasty for managing recurrent ureteropelvic junction obstruction • Performed laparoscopic vaginoplasty using a bowel segment in a young woman born without a vagina • Developed new, reliable prostate cancer diagnostic tools • Conducted studies demonstrating that salvage radiotherapy at low PSA after prostatectomy improves outcomes • Published a seminal laboratory guide for reproductive professionals • Constructed a new, state-of-the-art Cleveland Clinic East dialysis facility • Welcomed nearly 1,000 guests at our 14th annual 2016 Minority Men’s Health Fair I welcome your feedback, questions, and ideas for collaboration. Please contact me via email at [email protected], and reference the Glickman Urological & Kidney Institute in your message. Sincerely,

Eric A. Klein, MD Chairman, Glickman Urological & Kidney Institute Professor, Cleveland Clinic Lerner College of Medicine

4 Outcomes 2016

108374_CCFBCH_Text_4_Rev1.pdf 1 9/19/17 12:18 PM

Institute Overview

The Glickman Urological & Kidney Institute’s activities subspecialty training in one or more of the following encompass a unique combination of high-volume and areas: bladder, prostate, kidney, and testicular cancer; challenging clinical cases, extensive basic and translational bladder control; chronic urinary tract infections and scientific efforts, and innovative laboratory research within obstructions; dialysis; hypertension; kidney disease; an environment that nurtures the future leaders of its kidney transplantation; male fertility; pediatric urology specialties. U.S. News & World Report’s “Best Hospitals” and nephrology; prostate disease; sexual dysfunction/ survey has ranked the institute’s urology program as one of impotence; and genitourinary reconstruction. the top 2 programs in the United States every year since These subspecializations enable institute physicians to 2000. In 2016, the survey ranked the institute’s urology gain valuable experience using the latest techniques, and nephrology programs No. 2 in the nation. which fosters development of innovative procedures The institute’s 90 physicians and scientists offer expertise such as single-port laparoscopic and robotic surgery, in every subspecialty area. In 2016, the faculty served a autotransplantation for intractable kidney stone disease, significant number of patients; published 374 peer-reviewed focal therapy for prostate cancer, urethral reconstruction, manuscripts, 61 book chapters, and 4 textbooks; and and outpatient ureteral reimplantation. This environment secured $8.2 million in research funding. also provides an opportunity to compile meaningful The institute provides a full range of urologic and kidney outcomes data, which ultimately allows institute care for adults and children. Most physicians have physicians to better serve their patients.

Urological & Kidney Institute Overview 2016

Outpatient visits 96,474

Cases 8991

Dialysis treatments 19,695

Admissions 2060

Patient days 9291

Mean length of stay (days) 4.51

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2016 Statistical Highlights

Surgical/Interventional Procedures 6307

Benign Prostatic Hypertrophy Transplantation Photoselective vaporization 185 Kidney 240 Transurethral resection 253 Pancreas 12

Endourology and Stone Disease Urologic Oncology Lithotripsy 297 Adrenal Cancer Percutaneous renal surgery 282 Laparoscopic adrenalectomy 31 Robotic pyeloplasty 42 Open adrenalectomy 5 Ureteroscopy 318 Bladder Cancer Radical cystectomy with urinary diversion 214 Female Urology Transurethral resection of bladder tumor 881 InterStim® implants 274 Other procedures 9 Laparoscopic colpopexy 22 Kidney Cancer Sacrospinous ligament fixation 26 Laparoscopic nephroureterectomy 63 Vaginal prolapse repair 88 Laparoscopic radical nephrectomy 157 Vaginal sling procedures 200 Laparoscopic/robotic partial nephrectomy 327 Other procedures 324 Open nephroureterectomy 7 Open partial nephrectomy 82 Male Fertility Open radical nephrectomy 89 Microsurgical testicular sperm extraction 98 Prostate Cancer Varicocele ligation 36 Brachytherapy 284 Vasovasostomy 28 Laparoscopic/robotic radical prostatectomy 648 Other procedures 4 Radical retropubic (open) prostatectomy 86 Other procedures 4 Pediatric Surgeries 285 Testicular Cancer Prosthetics and Reconstruction Retroperitoneal dissection 55 Artificial sphincter 93 Penile prosthesis 117 Revisions/explants of genitourinary prosthetics 37 Tunical plication 22 Urethroplasty 82

6 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 6 8/31/17 3:14 PM In-Hospital Mortality

In-hospital mortality for patients admitted for urology services at the Urological & Kidney Institute is compared with that of similar-sized major teaching hospitals nationwide using APR DRGa methodology. Demographics and secondary diagnoses are used to calculate expected rates based on risk of mortality. The standardized mortality ratio is calculated as observed/expected, and a value < 1 indicates that mortality is lower than expected given the case mix. aThe 3M™ All Patient Refined Diagnosis Related Groups (APR DRG) Classification System is used for adjusting data for severity of illness and risk of mortality. solutions.3m.com/wps/portal/3M/en_US/Health-Information-Systems/HIS/Products-and-Services/Products-List-A-Z/APR-DRG-Software

In-Hospital Mortality: Urology

2012 – 2016 Standard Mortality Ratio 0.4

0.3

0.2

0.1

0 2012 2013 2014 2015 2016 Number of Admissions = 2456 2374 2184 2037 1924

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108374_CCFBCH_17OUT426_acg.indd 7 8/31/17 3:14 PM Length of Stay

Efficiency of care for patients at the Urological & Kidney Institute is assessed in part through hospital mean length of stay. Expected length of stay is calculated based on APR DRGa categories.

aThe 3M™ All Patient Refined Diagnosis Related Groups (APR DRG) Classification System is used for adjusting data for severity of illness and risk of mortality. solutions.3m.com/wps/portal/3M/en_US/Health-InformationSystems/HIS/Products-and-Services/Products-List-A-Z/APR-DRG-Software

Hospital Mean Length of Stay: Urology

2012 – 2016

Days 10 Expected length of stay 8

0 2012 2013 2014 2015 2016 N = 2456 2374 2184 2037 1924

8 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 8 8/31/17 3:14 PM Nephrology | Chronic Kidney Disease

Chronic Kidney Disease Clinic The Chronic Kidney Disease Clinic provides comprehensive medical care using a team approach for each patient, with a nephrologist, certified nurse practitioners, nursing staff, chronic kidney disease (CKD) educators, and a renal dietitian. More than 500 patients have been enrolled in the clinic. The Chronic Kidney Disease Clinic has several primary goals: • To delay the progression of CKD with the aim of easing the burden of end-stage renal disease (ESRD) • To reduce CKD morbidity and mortality through intensive cardiovascular risk management • To optimize transition to renal replacement therapies, such as dialysis and kidney transplantation Patients treated by the Chronic Kidney Disease Clinic are referred from Cleveland Clinic and non-Cleveland Clinic physicians for CKD evaluation and management. Patients’ electronic medical records are included in the CKD registry database, which provides fertile ground for identifying appropriate candidates for enrollment in clinical research projects. Patients included in the CKD registry have had at least 1 face-to-face outpatient encounter with a Cleveland Clinic health system healthcare provider and have had 2 estimated glomerular filtration rates (eGFRs) of < 60 mL/min/1.73 m2 more than 90 days apart as of June 1, 2005, and/or ICD-9 code diagnoses for kidney disease. The demographics and comorbidities of the more than 124,000 patients included in the registry are summarized in the following table.

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108374_CCFBCH_17OUT426_acg.indd 9 8/31/17 3:14 PM Nephrology | Chronic Kidney Disease

Characteristics of Chronic Kidney Disease Registry Patients Stratified by Disease Stage on Date of CKD Confirmation

2005 – 2016

ICD-9 Code Stage 3a Stage 4a Stage 5a Diagnosis Only Total Characteristic (N = 96,745) (N = 7826) (N = 2378) (N = 17,951) (N = 124,900)

Age, mean ± SD 71.7 ± 11.6 72.1 ± 13.9 61.6 ± 15.5 64.8 ± 15.9 70.5 ± 12.8 Years in registry, mean ± SD 4.1 ± 3.4 3.3 ± 3.2 2.6 ± 2.8 1.7 ± 2.3 3.7 ± 3.3 Gender, N (%) Female 52,819 (54.60) 4247 (54.27) 1056 (44.41) 7364 (41.02) 65,486 (52.43) Male 43,926 (45.40) 3579 (45.73) 1322 (55.59) 10,587 (58.98) 59,414 (47.57) Ethnic group, N (%) Missing 0 (0) 0 (0) 0 (0) 999 (5.57) 999 (0.80) White 84,760 (87.61) 6387 (81.61) 1546 (65.01) 11,561 (64.40) 104,254 (83.47) Black 10,814 (11.18) 1340 (17.12) 754 (31.71) 4934 (27.49) 17,842 (14.29) Asian 455 (0.47) 31 (0.40) 18 (0.76) 135 (0.75) 639 (0.51) Other 716 (0.74) 68 (0.87) 60 (2.52) 322 (1.79) 1166 (0.93) Comorbidities at inclusion, N (%) Diabetes mellitus 23,021 (23.80) 2353 (30.07) 798 (33.56) 8014 (44.64) 34,186 (27.37) Hypertension 83,969 (86.79) 6432 (82.19) 2040 (85.79) 14,652 (81.62) 107,093 (85.74) Coronary artery disease 20,712 (21.41) 1898 (24.25) 421 (17.70) 4219 (23.50) 27,250 (21.82) Congestive heart failure 8491 (8.78) 1220 (15.59) 275 (11.56) 2555 (14.23) 12,541 (10.04) Hyperlipidemia 75,978 (78.53) 5742 (73.37) 1589 (66.82) 12,754 (71.05) 96,063 (76.91) Cerebrovascular disease 9202 (9.51) 822 (10.50) 168 (7.06) 1648 (9.18) 11,840 (9.48)

aCKD stage at confirmatory eGFR using the Chronic Kidney Disease Epidemiology Collaboration equation

The CKD electronic medical record database allows analysis of the institute’s success rates in reaching prescribed guideline targets for anemia management, hyperlipidemia management, and CKD education. A recent analysis of these targets in more than 2000 CKD patients revealed excellent results. In aggregate, the protocol-driven, nurse-practitioner-run Chronic Kidney Disease Clinic showed superior performance vs a traditional general nephrology clinic. Additional studies are being designed to include patients with more advanced CKD whose disease is transitioning to ESRD.

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108374_CCFBCH_17OUT426_acg.indd 10 8/31/17 3:14 PM Process-of-Care Measures for Chronic Kidney Disease Patients During 1-Year Follow-Up

2014 – 2015

Nurse Nurse General General Odds Ratioa Practitioner Practitioner Nephrology Nephrology (95% CI) of Process-of-Care 2014 2015 2014 2015 Having Process Measure (N = 455) (N = 548) (N = 2126) (N = 2222) of Care 2015 Laboratory, N (%) Hemoglobin 441 (96.9) 526 (96.0) 1683 (79.2) 1798 (80.9) 5.1 (3.3-8.0) Serum calcium 446 (98.0) 537 (98.0) 1951 (91.8) 2050 (92.3) 3.5 (1.9-6.5) Serum phosphorus 418 (91.9) 511 (93.2) 1264 (59.5) 1391 (62.6) 8.2 (5.8-11.6) 25(OH)D 422 (92.7) 503 (91.8) 1016 (47.8) 1117 (50.3) 11.0 (8.0-15.1) Intact PTH 415 (91.2) 488 (89.1) 883 (41.5) 966 (43.5) 10.7 (8.0-14.2) Lipid profile 330 (72.5) 381 (69.5) 1234 (58.0) 1295 (58.3) 1.6 (1.3-1.9) Medication use, N (%) RAS blockers 240 (52.7) 282 (51.5) 1101 (51.8) 1165 (52.4) 1.0 (0.83-1.21) Statin 323 (71.0) 389 (71.0) 1228 (57.8) 1273 (57.3) 1.6 (1.3-2.0)

PTH = plasma parathyroid hormone, RAS = renin-angiotensin system a Logistic regression analysis adjusted for black race, Modification of Diet in enalR Disease estimated glomerular filtration rate at visit 1, and age at visit 1

These data document the positive impact that the Chronic Kidney Disease Clinic’s team approach has had on the effective management of medical issues relating to CKD. The clinic is working with other nationally recognized CKD centers to help establish benchmarks of care for CKD patients. A care path for optimal management of CKD patients is being developed.

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108374_CCFBCH_17OUT426_acg.indd 11 8/31/17 3:14 PM Nephrology | Chronic Kidney Disease

Body Mass Index and Causes of Death in Chronic Kidney Disease1 In chronic kidney disease (CKD), a higher body mass index (BMI) is associated with lower mortality risk, but cause-specific death details are unknown across the BMI range. Institute researchers studied 54,506 CKD registry entries to examine cardiovascular, malignancy, and noncardiovascular/nonmalignancy causes of death across the BMI range using Cox proportional hazards and competing risk regression models. During a median follow-up of 3.7 years, 14,518 patients died. The proportions of various causes of death among those in different BMI categories are shown below.

Causes of Death Across Body Mass Index Categories in Chronic Kidney Disease (N = 14,518)

2005 – 2012 Percent 50

40 Noncardiovascular/ 30 nommalignancy Cardiovascular 20 Malignancy Other causes 10

0 < 18.5 18.5 – 24.9 25 – 29.9 30 – 34.9 35 – 39.9 > 40 Body Mass Index

The multivariable model showed an inverted J-shaped association between BMI and cardiovascular-related, malignancy- related, and noncardiovascular/nonmalignancy deaths. Similar associations were noted for BMI categories of 25–29.9, 30–34.9, and 35–39.9 kg/m2. When compared with a BMI of 18.5–24.9, a BMI > 40 kg/m2 was not associated with an increased probability of cardiovascular-related and noncardiovascular/nonmalignancy deaths in CKD. Sensitivity analyses yielded similar results even after excluding patients with diabetes and/or hypertension and adjusting for proteinuria.

12 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 12 8/31/17 3:14 PM Predicted Mortality From Competing Risk Models at 4 Years Based on Body Mass Index in Chronic Kidney Disease (N = 14,518) Cardiovascular Death Malignancy Death Predicted Probability Predicted Probability 0.15 0.15

0.13 0.13

0.11 0.11 0.09 0.09

0.07 0.07

0.05 0.05

0.03 0.03 15 20 25 30 35 40 45 50 15 20 25 30 35 40 45 50 Body Mass Index Body Mass Index Noncardiovascular/Nonmalignancy Death Predicted Probability 0.15

0.13

0.11 0.09

0.07

0.05

0.03 15 20 25 30 35 40 45 50 Body Mass Index

In CKD, compared with those who have a BMI of 18.5–24.9 kg/m2, those who are overweight and those with class 1 and 2 obesity have a lower risk for cardiovascular-related, malignancy-related, and noncardiovascular/nonmalignancy-related deaths. Future studies should examine the associations of other measures of adiposity with outcomes in CKD.

Reference 1. Navaneethan SD, Schold JD, Arrigain S, Kirwan JP, Nally JV Jr. Body mass index and causes of death in chronic kidney disease. Kidney Int. 2016 Mar;89(3):675-682.

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108374_CCFBCH_17OUT426_acg.indd 13 8/31/17 3:14 PM Nephrology | Chronic Kidney Disease

Mortality in Patients With Chronic Kidney Disease and Chronic Obstructive Pulmonary Disease1 Chronic obstructive pulmonary disease (COPD) is associated with higher mortality in the general population. Institute researchers studied the associations between COPD and death and reported cause-specific death data among 56,960 patients with stage 3 or 4 chronic kidney disease (CKD) followed at Cleveland Clinic. Associations between COPD and all-cause mortality and specific causes of death (respiratory, cardiovascular, malignancy, and death due to other reasons) were analyzed using Cox proportional hazards and competing risk models. Of the 56,960 patients, 4.7% (N = 2667) had underlying COPD. Old age and presence of diabetes, hypertension, coronary artery disease, congestive heart failure, and smoking were associated with higher COPD risk. During a median follow-up of 3.7 years, 15,969 patients died. After covariate adjustment, COPD was associated with a 41% increased risk (95% CI 1.31-1.52) for all cause mortality and a fourfold increased risk (subhazard ratio 4.36, 95% CI 3.54-5.37) for respiratory-related deaths. Similar results were noted in a sensitivity analysis that was performed by defining COPD as the use of relevant ICD-9 codes and medications used to treat COPD.

Chronic Obstructive Pulmonary Disease Survival Impact in Chronic Kidney Disease

2005 – 2012 Proportion Alive 1.0

0.8

0.6 No COPD COPD 0.4 Log-rank P < 0.001

0.2

0 0 1 2 3 4 Years of Follow-up Number at Risk N = 54,293 46,559 39,490 32,342 25,236 2667 2008 1559 1123 811 COPD = chronic obstructive pulmonary disease

14 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 14 8/31/17 3:14 PM Associations of Various Causes of Death in Those With Chronic Obstructive Pulmonary Disease and Chronic Kidney Disease

2005 – 2012 Hazard and Subhazard Ratio (95% CI)

4.36 (3.54, 5.37)

2 1.41 (1.31, 1.52)

1.08 (0.92, 1.26) 1.03 (0.89, 1.20)

1 1.13 (0.99, 1.30)

0 All Cause Malignancy Cardiovascular Respiratory Other diseases

COPD is associated with a higher risk of death among those with CKD, and an underlying lung disease accounts for a significant proportion of deaths. These data highlight the need for further prospective studies to understand the underlying mechanisms and potential interventions to improve outcomes in this population.

Reference 1. Navaneethan SD, Schold JD, Huang H, Nakhoul G, Jolly SE, Arrigain S, Dweik RA, Nally JV Jr. Mortality outcomes of patients with chronic kidney disease and obstructive pulmonary disease. Am J Nephrol. 2016;43(1):39-46.

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108374_CCFBCH_17OUT426_acg.indd 15 8/31/17 3:14 PM Nephrology | Hypertension

Hypertension Control in Chronic Kidney Disease

The panel appointed to the Eighth Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure recommends a blood pressure (BP) goal of < 140/90 mm Hg in patients with chronic kidney disease (CKD).1 Although improved BP control is known to attenuate CKD progression, the rates of control reported in the literature are low. Among 3213 participants with varying stages of CKD in the National Health and Nutrition Examination Survey IV, 37% had BP controlled to 130/80 mm Hg; using the less stringent target of < 140/90 mm Hg, 56% of participants with varying stages of CKD had controlled BP.2 In an analysis of 10,813 participants with CKD from the Kidney Early Evaluation Program, only 13.2% had BP controlled to < 130/80 mm Hg, and 34% had BP controlled to < 140/90 mm Hg.3 Elevated systolic BP accounts for the majority of inadequate control.

Hypertension Control in Chronic Kidney Disease

2012 – 2016 Percent

80 Systolic blood pressure < 130 mm Hg 60 Systolic blood pressure < 140 mm Hg 40

0 2012 2013 2014 2015 2016 N = 2494 1905 2093 2446 3553

The Department of Nephrology and Hypertension searched electronic medical records of BP readings recorded at the last outpatient visit with a nephrologist in 2016. Among 3553 patients with an encounter diagnosis of moderately severe CKD (stages 3 and 4) and hypertension and at least 2 outpatient visits in 2016, 49% had systolic BP controlled to < 130 mm Hg, and 69% had systolic BP controlled to < 140 mm Hg. These control rates of hypertension in Cleveland Clinic CKD patients are higher than those published from cross-sectional studies.

References 1. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-520. 2. Peralta CA, Hicks LS, Chertow GM, Ayanian JZ, Vittinghoff E, Lin F, Shlipak MG. Control of hypertension in adults with chronic kidney disease in the United States. Hypertension. 2005 Jun;45(6):1119-1124. 3. Sarafidis PA, Li S, Chen SC, Collins AJ, Brown WW, Klag MJ, Bakris GL. Hypertension awareness, treatment, and control in chronic kidney disease. Am J Med. 2008 Apr;121(4):332-340.

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108374_CCFBCH_17OUT426_acg.indd 16 8/31/17 3:14 PM Nephrology | ICU Nephrology

The outcomes reported here are for patients who were seen on a regular nursing floor and subsequently transferred to the ICU, as well as new ICU renal consults. In-Hospital Mortality Grouped by Consultation Reason

2013 – 2016 Percent 80 2013 2014 60 2015 2016 40

0 Acute Kidney Injury Acute Kidney Injury End-Stage Othera With Dialysis Renal Disease Number at Risk N = 374 599 595 93 N = 344 615 669 101 N = 337 620 706 104 N = 366 660 797 89 aIncludes electrolyte abnormalities, hypertension, proteinuria, hematuria, and nephrolithiasis Incidence of Dialysis for Acute Kidney Injury by ICU Type

2013 – 2016 Percent 80 2013 2014 60 2015 2016 40

0 Medical Neurologic Surgical Coronary Heart Failure Cardiothoracic and Vascular Number at Risk N = 436 40 72 104 39 207 N = 449 35 67 110 46 191 N = 398 36 83 104 30 215 N = 469 39 86 116 25 195

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108374_CCFBCH_17OUT426_acg.indd 17 8/31/17 3:14 PM Nephrology | ICU Nephrology

In-Hospital Mortality in Patients With Acute Kidney Injury by ICU Type

2013 – 2016

Percent 2013 50 2014 2015 40 2016 30 20 10 0 Medical Neurologic Surgical Coronary Heart Failure Cardiothoracic and Vascular Number at Risk N = 436 40 72 104 39 207 N = 449 35 67 110 46 191 N = 398 36 83 104 30 215 N = 469 39 86 116 25 195

In-Hospital Mortality in Patients With End-Stage Renal Disease by ICU Type

2013 – 2016 Percent 40 2013 30 2014 2015 20 2016

0 Medical Neurologic Surgical Coronary Heart Failure Cardiothoracic and Vascular Number at Risk N = 307 26 17 97 13 73 N = 300 32 38 86 18 85 N = 329 41 38 95 21 76 N = 398 44 26 99 20 82

18 Outcomes 2016

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Kidney and Pancreas Transplants Kidney Transplant Program Summary Kidney transplant program volume increased 2016 substantially in 2016 with a total of 162 kidney transplants, representing an increase of 16.5% from Cleveland Clinic 2015. There were 137 kidney transplants, Deceased donor transplants, N 75 6 simultaneous kidney-pancreas, 17 simultaneous liver- Living donor transplants, N 62 kidney, 1 simultaneous heart-kidney, and Total waiting list, N 663a 1 kidney with a multivisceral transplant. There was Active on waiting list, N 514a 1 pancreas transplant. The program has continued to a see significant demand for services with 1273 referrals New patient registrations, N 269 a for transplantation, an increase of 26.3% from 2015. Data for July 2015 to June 2016 based on Scientific Registry of Transplant Recipients data available as of Oct. 31, 2016. According to the most recent US Scientific Registry of Transplant Recipients report, Cleveland Clinic transplant rates exceeded expected values, and wait-list mortality Kidney Wait-List Outcomes was slightly lower than expected. Overall, patient and July 2015 – June 2016 graft survival at 1 year were not different than expected. Rate Observed Expected Cleveland Clinic continues to have a high percentage of listed patients in active status and the shortest Kidney transplant rate for 21.1 18.4 waiting time of centers in northeast Ohio. The median wait-list patients, % time to transplant in 2016 was 36.6 months — better Mortality rate while on wait-list, % 4.1 5.3 than the 57.6 months for the local organ procurement Source: Scientific Registry of Transplant Recipients, based on data organization, the 49.5 months for United Network for available as of Oct. 31, 2016 Organ Sharing region 10 (Ohio, Indiana, and Michigan), and the nationwide median transplant times with the Posttransplant Outcomes at 1 Year 50th percentile of listed patients not reached. July 2014 – June 2015 The institute continues to support a robust living donor program. In 2016, there were 62 living donor kidney Survival Observed Expected transplants, including 14 paired donations in affiliation Adult graft survival (based on 316 93.61 95.61 with the National Kidney Registry, bringing total paired transplants), % donations to 56 since program initiation in 2011. Adult patient survival (based on 98.30 97.74 Additionally, there were 3 altruistic donors. 279 transplants), % Pediatric graft survival (based on 100 7 transplants), % Pediatric patient survival (based 100 on 6 transplants), % Source: Scientific Registry of Transplant Recipients, based on data available as of Oct. 31, 2016

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Posttransplant Outcomes at 1 Year — Adult Graft Survival Percent Survival 100 80

60 Observed 40 Expected 20 0 7/1/11 – 7/1/12 – 7/1/13 – 7/1/14 – 7/1/15 – 6/30/12 6/30/13 6/30/14 6/30/15 6/30/16 N = 340343 382355 316

Posttransplant Outcomes at 1 Year — Adult Patient Survival Percent Survival 100 80

60 Observed 40 Expected 20 0 7/1/11 – 7/1/12 – 7/1/13 – 7/1/14 – 7/1/15 – 6/30/12 6/30/13 6/30/14 6/30/15 6/30/16 N =295 300336 313279

The Urological & Kidney Institute maintains a strong commitment to developing new therapies for its patients and is participating in a National Institutes of Health trial to determine the efficacy of infliximab given at transplantation on 2-year kidney function and survival. The institute is also involved in several industry-sponsored studies of whether newer therapies given at the time of transplant will reduce delayed graft function, requiring dialysis that can prolong hospital stay. Cleveland Clinic has also expanded the transplantation outreach program at the affiliated Akron General Hospital. This pretransplant evaluation clinic started in March 2015 and is held 1–2 days per month. Patients are now evaluated by a transplant coordinator, nephrologist, and social worker at a location more convenient for them. In 2016, 45 patients were evaluated. Finally, the institute initiated a continuous improvement project to help improve performance in evaluating referrals. This will drive efficiency in the program.

20 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 20 8/31/17 3:14 PM Urology | Bladder/Voiding Dysfunction

Same Day Discharge After Robotic-Assisted Pelvic Floor Reconstruction Discharge after a 1-night hospitalization is the currently accepted practice following robotic-assisted pelvic floor reconstruction (RAPFR). To assess whether same day discharge (SDD) affects the short-term safety of RAPFR relative to next day discharge, medical records for 7 overnight patients and 7 SDD patients were evaluated for any unscheduled Cleveland Clinic emergency department (ED) and/or office visits within 7 days of the RAPFR procedure. The charts of 14 women who underwent RAPFR procedures were retrospectively reviewed between May 2016 and September 2016. Patients in the SDD group were no more likely than the overnight group to require an unscheduled ED or office visit in the early postoperative period; in this cohort there were no unscheduled ED and/or office visits within 7 days of RAPFR. RAPFR procedures were well tolerated regardless of length of stay. SDD appears safe and feasible, with a significant decrease in treatment cost.

Feasibility of Same Day Discharge After Robotic-Assisted Pelvic Floor Reconstruction (N = 14) May 2016 – September 2016

Unscheduled Emergency Unscheduled Office Visits Department Visits Within 7 Days Within 7 Days of Procedure Discharge Method (N) of Procedure (N) (N) Overnight (7) 0 0 Same day (7) 0 0

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Renal Cell Carcinoma Five-Year Overall Survival of Patients With All Stages of Renal Cell Cancer (N = 3593) 2007 – 2015 Survival (%) 100100 Cleveland Clinic SEERa 8080 6060 aHowlader N, Noone AM, Krapcho M, et al. (eds). SEER Cancer Sta- 4040 tistics Review, 1975-2013, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2013/, based on 2020 November 2015 SEER data submission, posted to the SEER website, 00 Apr. 2016. Accessed March 21, 2017. 0 21 3 4 5 Years After Diagnosis

Number at Risk 3013 2485 1850 1796 672

Five-Year Overall Survival of Patients With Renal Cell Cancer by Stagea at Diagnosis (N = 3349) 2007 – 2015 Survival (%) 100100 Stage I CC (N = 2053) 8080 Stage II CC (N = 154) Stage III CC (N = 744) 6060 Stage IV CC (N = 398) 4040 2020 00 0 21 3 4 5 Years After Diagnosis Number at Risk Stage I (N = 2053) 1830 1548 1148 720 445 Stage II (N = 154) 139 114 82 53 35 Stage III (N = 744) 623 512 356 205 108 Stage IV (N = 398) 210 134 76 47 25 CC = Cleveland Clinic aAmerican Joint Committee on Cancer (AJCC) stage 0–V renal cell carcinoma

22 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 22 8/31/17 3:14 PM Effects of Pharmacologic Venous Thromboembolism Prophylaxis After Robot-Assisted Partial Nephrectomy1

Urological & Kidney Institute researchers retrospectively examined 1005 robot-assisted partial nephrectomy database cases performed between 2006 and 2014 and documented clinical venous thromboembolism episodes occurring within 6 months of surgery. Patients who received pharmacologic venous thromboembolism prophylaxis (N = 222) and those who did not (N = 778) were compared in terms of perioperative outcomes, complications, and adverse hemorrhagic events (defined as the administration of 2 or more units of red blood cells, the need for vascular embolization, or any procedures related to blood loss).

Patient Selection by Pharmacologic Prophylaxis Status (N = 1005) 2006 – 2014

Only preoperative pharmacologic prophylaxis (N = 5)

Preoperative + postoperative Pharmacologic pharmacologic prophylaxis prophylaxis (N = 222) (N = 50)

Only postoperative pharmacologic prophylaxis (N = 167) Robot-assisted partial nephrectomy No antiplatelet drugs (N = 1005) (N = 762) No pharmacologic prophylaxis (N = 778) Aspirin (N = 16)

Excluded (N = 5)

Rates of venous thromboembolism were comparable between the pharmacologic prophylaxis and no prophylaxis groups at 1.8% and 2.1%, respectively (P = 0.75). The administration of pharmacologic prophylaxis did not increase the rate of adverse hemorrhagic events. Isolated inpatient administration of pharmacologic prophylaxis after robot-assisted partial nephrectomy does not appear to protect against postoperative venous thromboembolism.

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Summary of Venous Thromboembolism Events (N = 1000) 2006 – 2014

Percent 3 P = 0.75 Pulmonary embolism Deep venous thrombosis 2

0 Pharmacologic Nonpharmacologic Prophylaxis Prophylaxis N = 4 16

Reference 1. Kara O, Zargar H, Akca O, Andrade HS, Caputo P, Maurice MJ, Ramirez D, Stein RJ, Kaouk JH. Risks and benefits of pharmacological prophylaxis for venous thromboembolism prevention in patients undergoing robotic partial nephrectomy. J Urol. 2016 May;195(5):1348-1353.

High Irrigation Pressure and Inflammatory Response Syndrome After Percutaneous Nephrolithotomy1

Percutaneous nephrolithotomy (PCNL) is the procedure of choice for large kidney stones (> 2 cm). Continuous pressurized irrigation is used during the procedure to maintain visibility and adequate working space. The irrigation pressure used may be directly related to the development of systemic inflammatory response syndrome (SIRS) after PCNL with the attendant risk of progressing to urosepsis and septic shock. Institute investigators performed a randomized controlled trial to assess the effect of irrigation pressure on SIRS. Between January 2014 and March 2016, 90 patients undergoing PCNL were randomized to low (80 mm Hg) or high (200 mm Hg) irrigation pressure. High pressure irrigation was associated with a higher risk of SIRS (46%) compared with low pressure irrigation (11%, P < 0.0002). On multivariate analysis, high irrigation pressure, paraplegia or neurogenic bladder, and nonquinolone perioperative antibiotics were predictive of postoperative SIRS. Although comparison between the high and low pressure groups indicated significantly better visualization during the procedure, there was no difference in stone free rates or complications. This trial showed that high pressure irrigation during PCNL increases the risk of postoperative SIRS, with no significant improvement in outcomes.

24 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 24 8/31/17 3:14 PM High vs Low Pressure Surgical Outcomes and Complications (N = 90)

January 2014 – March 2016

Low Pressure High Pressure P Value Stone-free, N (%) 34 (81) 41 (91) 0.1 Mean residual stone diameter, mm (± SD) 0.9 ± 0.3 0.7 ± 0.4 0.7 Residual stones, N (%) 0.5 Computed tomography 15 (36) 11 (24) Fluoroscopy 22 (52) 25 (56) Plain KUB x-ray 4 (10) 8 (18) Renal ultrasound 1 (2) 1 (2) Intraoperative visualization, N (%) 0.0001 Excellent 0 (0) 6 (15) Good 8 (20) 21 (54) Fair 28 (68) 11 (28) Poor 5 (12) 1 (3) Clavien score, N (%) 0.3 I 39 (89) 42 (91) II 3 (7) 1 (20) IIIa 1 (2) 3 (7) IVa 1 (2) 0 (0) SIRS incidence, % 11 46 0.0002 KUB = kidney, ureter, and bladder, SIRS = systemic inflammatory response syndrome Multivariate Analysis of Systemic Inflammatory Response Syndrome Predictors

January 2014 – March 2016

Characteristics P Value Age 0.8 Gender 0.7 Comorbidity (paraplegia, neurogenic bladder) < 0.001 Irrigation pressure 0.0008 Stone composition 0.6 Perioperative quinolone 0.0031

Reference 1. Omar M, Noble M, Sivalingam S, El Mahdy A, Gamal A, Farag M, Monga M. Systemic inflammatory response syndrome after percutaneous nephrolithotomy: a randomized single-blind clinical trial evaluating the impact of irrigation pressure. J Urol. 2016 Jul;196(1):109-114.

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108374_CCFBCH_17OUT426_acg.indd 25 8/31/17 3:14 PM Urology | Kidney

Effects of Supplemental Calcium and Vitamin D in Recurrent Stone Formers

The institute studied the effects of calcium and vitamin D supplementation on kidney stone growth based on follow-up computed tomography (CT) scans and 24-hour urine composition. Of 6050 current stone formers seen at Cleveland Clinic from 2003 to 2014, 426 who had at least 2 CT scans demonstrating kidney stones at least 30 days apart and in less than 2 years were included in the analysis. Patients who had a surgical intervention for a kidney stone between the two CT scans were excluded. A total of 2061 patients who had at least 2 24-hour urine collections were included in the metabolic studies. The first 24-hour urine collection had to have taken place prior to initiation of calcium and/or vitamin D supplementation, and the second 24-hour urine collection had to have taken place at least 30 days after starting the supplementation. Methods 2003 – 2014

6050 patients with 6050 patients with urolithiasis identified by history of urolithiasis computed tomography scan

426 patients met criteria: 2061 had 24-hour urine collections before 2 unenhanced CT scans > 30 days but < 2 years and after starting supplementation apart during the time of supplementation

1486 calcium 417 vitamin D 195 calcium +/- 460 mg/d ± 127 vitamin D 104 no 3005 IU D3/d vitamin D 2726 IU D3/d 58 none supplement supplement or 6307 IU supplement or 5678 IU D2/d D2/d

26 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 26 8/31/17 3:14 PM Patients on calcium supplementation had a higher rate of stone formation than those on vitamin D supplementation alone. On average, the rate of stone formation for those on calcium was 7.8 mm/year compared with 3.3 mm/year (P = 0.0105). Multiple linear regression showed an inverse association between vitamin D3 and stone formation (P = 0.049). Patients on calcium with or without vitamin D supplementation had a decrement in urinary calcium with a mean of -5.1 mg/day before and after supplementation (P = 0.021). For those on vitamin D alone, there was a decrease in urinary calcium of -8.9 mg/day (P = 0.011). There were also statistically significant decreases in urinary oxalate excretion for those on calcium with or without vitamin D (-4.2 mg/day) and vitamin D alone (-3.1 mg/day) (P < 0.0001). In conclusion, patients on calcium supplementation had higher rates of stone formation, and vitamin D supplementation may have beneficial effects on recurrent stone formers. In addition, 24-hour metabolic analyses showed significant changes in urinary calcium and oxalate excretion with vitamin D supplementation, suggesting a possible protective effect.

Role of Parenchymal Mass Reduction and Ischemia on Functional Recovery After Partial Nephrectomy1

Acute increase of serum creatinine (SCr) after partial nephrectomy (PN) is primarily due to parenchymal mass reduction or ischemia; however, only ischemia can impact subsequent functional recovery. The institute evaluated etiologies of acute kidney injury (AKI) after PN and their prognostic significance. From 2007 to 2014, 83 solitary kidneys managed with PN had necessary studies for detailed analysis of function and parenchymal mass before and after surgery. AKI was classified by risk/injury/failure/loss/end-stage grade and defined by either standard criteria (comparison to preoperative SCr) or proposed criteria (comparison to projected postoperative SCr based on parenchymal mass reduction). Subsequent recovery was defined as percent function preserved/percent mass saved. Median duration of warm ischemia (N = 39) was 20 minutes and hypothermia (N = 44) was 29 minutes. Median parenchymal mass reduction was 11%. AKI occurred in 45 patients based on standard criteria and 38 based on proposed criteria, and reflected injury/failure (grade = 2/3) in 23 and 16 patients, respectively. On multivariable analysis, only ischemia time was associated with AKI occurrence (P = 0.016). Based on the proposed criteria, median recovery from ischemia was 99% in patients without AKI and 95%/90%/88% for patients with grades 1/2/3 AKI, respectively. The coefficient for association between AKI grade based on proposed criteria and subsequent functional recovery was -4.168 (P = 0.018). The main limitation of this study is a limited patient cohort. Parenchymal mass reduction and ischemia both contribute to acute changes in SCr after PN. Classification of AKI by proposed criteria is significantly associated with subsequent functional recovery. However, more robust numbers will be needed to further assess the merits of the proposed criteria. While AKI is associated with suboptimal recovery, even patients with grade 2/3 AKI reached 88% to 90% of recovery expected.

Reference 1. Zhang Z, Zhao J, Dong W, Remer E, Li J, Demirjian S, Zabell J, Campbell SC. Acute Kidney Injury after Partial Nephrectomy: Role of Parenchymal Mass Reduction and Ischemia and Impact on Subsequent Functional Recovery. Eur Urol. 2016 Apr;69(4):745-752.

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Robot-Assisted Partial Nephrectomy With Intracorporeal Renal Hypothermia Using Ice Slush

Cleveland Clinic urologists have introduced the concept of intracorporeal cooling of the kidney during robot-assisted partial nephrectomy (RAPN) to minimize ischemic damage. Cases were included and selected for intracorporeal cooling if preoperative assessment estimated that warm ischemia time would be > 30 minutes, determined by whether the patient had a complex renal mass. Researchers retrospectively compared 28 cold ischemia patients with a matched group of 36 patients undergoing robot-assisted partial nephrectomy under warm ischemia. Strategies for successful ice slush intracorporeal renal cooling include placement of an accessory port directly over the kidney, uniform ice consistency, modified syringes, sequential clamping of the renal artery and vein, protection of the neighboring intestine with a laparoscopic sponge, and complete mobilization of the kidney. Kidney temperature is monitored via a needle thermocouple device, and core body temperature is concurrently monitored via an esophageal probe in real time. Renal function was assessed by serum creatinine level, estimated glomerular filtration rate (eGFR), and mercaptoacetyltriglycine renal scan, both perioperatively and at 6-month follow-up. Cold ischemia during RAPN was found to be associated with a 12.9% improvement in preservation of postoperative eGFR. No difference was seen in eGFR between patients with cold ischemia and the matched group of warm ischemia patients at 6-month follow-up. RAPN with intracorporeal renal hypothermia using ice slush is technically feasible and may improve postoperative renal function in the short term. This technique for intracorporeal hypothermia is cost-effective, simple, and highly reproducible.

Intraoperative Data (N = 28)

2013 – 2015

Variable Mean Median Range Estimated blood loss, mL 162 100 25 – 800 Operating time, min 209 200 120 – 395 Ischemia time, min 32 29 18 – 56 Time for slush placement, min 5.2 5 2 – 10 Coldest renal temperature, °C 14.8 13 10 – 26 Time to lowest renal temperature, min 10.2 10 3 – 20 Patient start temperature, °C 36.1 36 35 – 37 Patient coldest temperature, °C 35.5 35 35 – 37 Change in patient temperature, °C 0.3 0 0 – 1 Volume of ice slush, mL 640 650 400 – 800

28 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 28 8/31/17 3:14 PM Postoperative and Functional Data (N = 28)

2013 – 2015

Variable Mean Median Range Length of stay, days 3.2 3 2 – 7 Postoperative eGFR at 1 week, mL/min/1.73 m2 60.9 63.5 16 – 103.4 Degree of eGFR preservation, 1 week, % 85.3 85 45 – 116 eGFR at 6 months, mL/min/1.73 m2 65.1 62 33 – 108 Degree of eGFR preservation at 6 months, % 86.8 91 62 – 126 Degree of ipsilateral differential functional preservation at 79.9 78 60 – 100 6 months assessed by nuclear medicine renal scan, % eGFR = estimated glomerular filtration rate

Reference 1. Ramirez D, Caputo PA, Krishnan J, Zargar H, Kaouk JH. Robot-assisted partial nephrectomy with intracorporeal renal hypothermia using ice slush: step-by-step technique and matched comparison with warm ischaemia. BJU Int. 2016 Mar;117(3):531-536.

Functional Recovery From Extended Warm Ischemia After Partial Nephrectomy1

From 2007 to 2014, 277 patients managed with partial nephrectomy (PN) had appropriate studies to evaluate changes in function and mass within the operated kidney. Recovery from ischemia was defined as percent function saved/percent parenchymal mass saved. Acute kidney injury (AKI) was based on global renal function and defined as a ≥ 1.5-fold increase in serum creatinine above the preoperative level. Hypothermia (median 27 minutes) was used in 112 patients and warm ischemia (median 21 minutes) in 165 patients. AKI strongly correlated with a solitary kidney (P < 0.001) and duration (P < 0.001) but not type (P = 0.49) of ischemia. Median recovery from ischemia in the operated kidney was 100% (interquartile range [IQR] = 88%–109%) for cold ischemia, with 6 patients (5%) noted to have < 80% recovery. For the warm ischemia group, median recovery from ischemia was 91% (IQR = 82%–101%, P < 0.001 compared with hypothermia), and 34 patients (21%) had recovery from ischemia < 80% (P < 0.001). For warm ischemia subgrouped by duration < 25 minutes (N = 114), 25–35 minutes (N = 35), and > 35 minutes (N = 16), median recovery from ischemia was 92% (IQR = 86%–100%), 90% (IQR = 78%–100%), and 91% (IQR = 80%–96%), respectively (P = 0.77).

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Impact of Type and Duration of Ischemia on Functional Recovery (N = 277)

2007 – 2014

Recovery from Ischemia (%) 140

120 Q4 100 Q3 101 100 96 99 92 91 Q1 91 90 80 Q1

20 Cold Warm <25 2 – 35 >35 <25 25 – 35 >35 ischemia ischemia Cold ischemia time (min) Cold ischemia time (min)

The box plots show median values with interquartile ranges (IQRs). Extreme values, defined as those more than 1.5 times the IQR away from either Q1 or Q3, are shown as individual points. The range of values is also shown excluding the extreme points. Hypothermia (blue) and warm ischemia (purple) cohorts are shown along with a breakdown of ischemic intervals.

The results suggest that AKI after PN correlates with duration but not with type of ischemia. However, subsequent recovery, which ultimately defines the new baseline glomerular filtration rate, is most reliable with hypothermia. Most patients undergoing PN with warm ischemia still recover relatively strongly from ischemia, even if extended to 35–45 minutes.

Reference 1. Zhang Z, Zhao J, Velet L, Ercole CE, Remer EM, Mir CM, Li J, Takagi T, Demirjian S, Campbell SC. Functional recovery from extended warm ischemia associated with partial nephrectomy. Urology. 2016 Jan;87:106-113.

30 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 30 8/31/17 3:14 PM Renal Cell Carcinoma: 5-Year Oncologic Outcomes After Transperitoneal Robot-Assisted Partial Nephrectomy1

Robot-assisted partial nephrectomy (RPN) is established as a minimally invasive nephron-sparing technique with excellent perioperative and intermediate oncologic outcomes. To determine the long-term outcomes associated with the procedure, consecutive patients undergoing RPN at Cleveland Clinic from June 2006 to March 2010 were prospectively selected from the RPN database. Patients with benign tumors, prior ipsilateral partial nephrectomy, prior radical nephrectomy, and those with follow-up of < 1 month were excluded.

Long-Term Robot-Assisted Partial Nephrectomy Outcomes Selection Process (N = 115)

June 2006 – March 2010

183 RPNs

50 benign tumors 133 malignant tumors

16 lost to 1 prior ipsilateral 1 prior radical 115 RPNs follow-up within RPN nephrectomy included 1 month

5 patients 6 patients with 99 patients with underwent 10 multiple ipsilateral single tumor staged RPNs tumors

RPN = robot-assisted partial nephrectomy

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Demographic and Preoperative Data for Patients Undergoing Robot-Assisted Partial Nephrectomy (N = 110)

June 2006 – March 2010

Variable Value Patients/robot-assisted partial nephrectomy procedures, N 110/115 Mean age, years (SD) 59.8 (11) Males, N (%) 73 (66) White, N (%) 106 (96) Right side, N (%) 56 (51) Mean body mass index, kg/m2 (SD) 30.4 (6.9) Median age-adjusted Charlson comorbidity index (IQR) 4 (3 – 5) Median tumor size, cm (IQR) 2.6 (2.0 – 3.7) Clinical stage, N (%) T1a 91 (79) T1b 20 (17.4) T2a 4 (3.6) Median RENAL score (IQR) 7 (6 – 9) Low score (4 – 6), N (%) 37 (32) Moderate score (7 – 9), N (%) 60 (52) High score (10 – 12), N (%) 18 (16) Median preoperative eGFR, mL/min/1.73m2 (IQR) 85.9 (67.8 – 96.1) eGFR = estimated glomerular filtration rate, IQR = interquartile range, SD = standard deviation

32 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 32 8/31/17 3:14 PM Perioperative, Postoperative, and Pathologic Data (N = 115)

June 2006 – March 2010

Variable Value Median operative time, min (IQR) 180 (150 – 215) Median estimated blood loss, mL (IQR) 200 (100 – 350) Median warm ischemia time, min (IQR) 20 (16 – 27) Intraoperative complications, N (%) 7 (6.1) Postoperative complications, N (%) 28 (24) Clavien-Dindo I 8 (28) Clavien-Dindo II 15 (54) Clavien-Dindo IIIa 5 (18) Median length of stay, days (IQR) 3 (3 – 5) Median follow-up, months (IQR) 61.9 (50.9 – 71.4) Median postoperative eGFR, mL/min/1.73m2 (IQR) 69.6 (57.6 – 87.2) Median eGFR preservation, % (IQR) 87.8 (74.9 – 98.1) Chronic kidney disease upstaging, N (%) 21 (19.1) Trifecta criteria met, N (%) 62 (53.9) Histology, N (%) Clear cell 78 (68) Papillary 26 (23) Chromophobe 6 (5) Unclassified 5 (4) Pathologic T stage, N (%) T1a 90 (78) T1b 18 (16) T2a 2 (2) T3a 5 (4) Fuhrman grade ≥ 3, N (%) 24 (21) Positive surgical margins, N (%) 2 (1.7) Recurrence, N (%) 0 (0) Metastasis, N (%) 2 (1.8) eGFR = estimated glomerular filtration rate, IQR = interquartile range, SD = standard deviation

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Survival of Patients Undergoing Robot-Assisted Partial Nephrectomy (N = 110)

June 2006 – March 2010 Probability of Overall Survival Probability of Cancer-specific Survival 1.0 1.0

0.8 0.8

0.6 0.6

0.4 0.4

0.2 0.2

0.0 0.0 0 12 24 36 48 60 0 12 24 36 48 60 Number Months Number Months at risk 110 105 97 93 87 62 at risk 110 105 97 93 87 62

Univariate Logistic Regression Analysis of Variables Predicting Overall Mortality (N = 110)

June 2006 – March 2010

Variable Odds Ratio P Value Age-adjusted Charlson comorbidity index 1.67 0.006 Absence of trifecta 4.72 0.06 Glomerular filtration rate preservation 1.01 0.5 RENAL score 4 – 6 1.0 (reference) RENAL score 7 – 9 1.82 0.5 RENAL score 10 – 12 2.19 0.4 Clear cell renal cell carcinoma 2.82 0.14 High Fuhrman grade 2.16 0.3

Reference 1. Andrade HS, Zargar H, Caputo PA, Akca O, Kara O, Ramirez D, Haber GP, Stein RJ, Kaouk JH. Five-year oncologic outcomes after transperitoneal robotic partial nephrectomy for renal cell carcinoma. Eur Urol. 2016 Jun;69(6):1149-1154.

34 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 34 8/31/17 3:14 PM Robot-Assisted vs Open Partial Nephrectomy for Completely Endophytic Renal Tumors1 Completely endophytic renal tumors have traditionally been treated using open partial nephrectomy (OPN) due to the complex dissection required for complete excision. Institute urologists have extended the technique of robot-assisted partial nephrectomy (RAPN) to include these complex cases, providing patients the advantage of improved cosmesis and enhanced recovery. There were 1230 consecutive cases, consisting of 823 RAPN and 407 OPN, performed for renal mass between 2011 and 2015. Of these, data on 87 RAPN and 56 OPN cases for completely endophytic renal tumors were analyzed. Demographics and Tumor Characteristics (N = 143)

2011 – 2015

Patient Variables RAPN (N = 87) OPN (N = 56) P Value Mean age, years (SD) 58.3 (11.8) 61.1 (11) 0.71 Surgical cases per year, N (%) 2011 10 (11.5) 13 (23.2) 0.19 2012 18 (20.7) 16 (28.6) 2013 23 (26.4) 11 (19.6) 2014 22 (25.3) 10 (17.9) 2015 14 (16.1) 6 (10.7) White, N (%) 72 (82.8) 49 (87.5) 0.44 Male, N (%) 45 (51.7) 35 (62.5) 0.2 Solitary kidney, N (%) 5 (5.7) 12 (21.4) 0.005 Preoperative chronic kidney disease, N (%) 16 (18.6) 14 (25) 0.4 Median body mass index, kg/m2 (IQR) 29 (25.4 – 33.3) 29.5 (25.7 – 35.7) 0.66 Median Charlson comorbidity index, (IQR) 1 (0 – 2) 1 (0 – 2) 0.15 Median preoperative eGFR, mL/min/1.73 m2 (IQR) 84.7 (67.6 – 98.6) 78.9 (57.4 – 89.4) 0.14 eGFR = estimated glomerular filtration rate, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy, SD = standard deviation

Tumor Variables RAPN (N = 87) OPN (N = 56) P Value Median tumor size on CT, cm (IQR) 2.8 (2.1 – 3.7) 3.1 (3.3 – 4.6) 0.07 Median RENAL score (IQR) 9 (9 – 10) 9 (8 – 10) 0.35 RENAL complexity class, N (%) Low (4 – 6) 4 (4.6) 5 (8.9) 0.43 Moderate (7 – 9) 43 (49.4) 23 (41.1) High (10 – 12) 40 (46) 28 (50) CT = computed tomography, IQR = interquartile range, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

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Intraoperative and Postoperative Outcomes (N = 143)

2011 – 2015

Variable RAPN (N = 87) OPN (N = 56) P Value Intraoperative Mean operation time, min (SD) 185 (60.3) 206 (63.1) 0.06 Mean estimated blood loss, mL (SD) 175 (166.3) 341 (284.4) < 0.001 Warm ischemia, N (%) 77 (88.5) 13 (14.4) Median (IQR) time, min 24 (18 – 29.7) 20.6 (16.7 – 21.7) 0.15 Cold ischemia, N (%) 10 (11.5) 41 (80.4) Median (IQR) time, min 28 (23.8 – 44.2) 34 (24.7 – 49.5) 0.28 Unclamped, N (%) 0 (0) 2 (3.6) Intraoperative transfusion, N (%) 0 (0) 4 (7.1) 0.02 Positive margin, N (%) 4 (5.4) 4 (8.7) 0.48 Postoperative Median length of stay, days, (IQR) 3 (2 – 4) 5 (4 – 6) < 0.001 Postoperative transfusion, N (%) 5 (6) 7 (12.5) 0.18 30-day readmission, N (%) 2 (2.3) 5 (8.9) 0.11 IQR = interquartile range, SD = standard deviation

36 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 36 8/31/17 3:14 PM Intraoperative and Postoperative Complications (N = 143)

2011 – 2015

Complication, N (%) RAPN (N = 87) OPN (N = 56) P Value Intraoperative complications 1 (1.1) 1 (1.7) 0.75 Pleural injury requiring chest tube 0 (0) 1 (1.1) Renal artery injury 1 (1.1) 0 (0) Postoperative complications, Clavien grade I – V 18 (20.7) 20 (35.7) 0.08 Major complications, Clavien grade III – IV 4 (4.5) 5 (8.9) 0.85 Clavien grade II complications 12 (13.7) 14 (25) Transfusion 3 (3.4) 2 (3.5) Pneumonia 2 (2.3) 0 (0) Gross hematuria and clot retention 1 (1.1) 0 (0) Urinary tract infection 1 (1.1) 1 (1.7) Atrial fibrillation requiring treatment 4 (4.6) 2 (3.5) Deep venous thromboembolism 1 (1.1) 3 (5.5) Wound infection requiring antibiotics 0 (0) 5 (8.9) Ileus requiring total parenteral nutrition 0 (0) 1 (1.7) Clavien grade III complications 4 (4.5) 4 (7.2) Urine leakage requiring JJ stent 0 (0) 1 (1.7) Embolization (arteriovenous fistula hematuria) 3 (3.4) 2 (3.5) Acute kidney injury (oliguria) 0 (0) 1 (1.7) Ogilvie syndrome requiring colonoscopy 1 (1.1) 0 (0) Clavien grade IV complications 0 (0) 1 (1.7) Acute kidney injury requiring hemodialysis 0 (0) 1 (1.7) OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

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Pathologic Outcomes and Follow-Up Data (N = 143)

2011 – 2015

Variable RAPN (N = 87) OPN (N = 56) P Value Malignant disease, N (%) 74 (85.1) 47 (83.9) 0.85 Clear cell renal cell carcinoma 54 (73.0) 29 (61.7) 0.51 Papillary renal cell carcinoma 6 (8.1) 7 (14.9) Chromophobe renal cell carcinoma 7 (9.5) 6 (12.8) Mixed component renal cell carcinoma 2 (2.7) 3 (6.4) Other malignant diseases 5 (6.8) 2 (4.3) T stage, N (%) T1a 53 (71.6) 30 (63.8) 0.3 T1b 9 (12.2) 4 (8.5) T2a 1 (1.4) 0 (0) T3a 11 (14.9) 13 (27.7) Tumor grade, N (%) 1 and 2 37 (56.1) 25 (61.0) 0.61 3 and 4 29 (43.9) 16 (39.0) Median (IQR) Follow-up, months 15.2 (7 – 27.2) 18.1 (8.2 – 30.9) 0.12 Postoperative 3rd day eGFR, mL/min/1.73m2 70.1 (56.7 – 85.4) 62.2 (43.1 – 75.5) 0.03 Postoperative 3rd day % eGFR preservation 82.9 (70.4 – 100) 79.3 (65.4 – 98.4) 0.26 Latest eGFR, mL/min/1.73m2 71 (54.6 – 90) 67 (45.7 – 78.9) 0.07 Latest follow-up % eGFR preservation 85.2 (76.4 – 93.3) 82.9 (73.1 – 91.9) 0.22 Oncologic outcomes, N (%) Local recurrence 0 (0) 0 (0) Metastasis 0 (0) 0 (0) eGFR = estimated glomerular filtration rate, IQR = interquartile range, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

Reference 1. Kara O, Maurice MJ, Malkoc E, Ramirez D, Nelson RJ, Caputo PA, Stein RJ, Kaouk JH. Comparison of robot-assisted and open partial nephrectomy for completely endophytic renal tumours: a single centre experience. BJU Int. 2016 Dec;118(6):946-951.

38 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 38 8/31/17 3:14 PM Robot-Assisted Partial Nephrectomy Improves Outcomes in Obese Patients1 Obese patients are at high risk for surgical complications, particularly wound related complications. Institute researchers analyzed surgical complications for obese patients undergoing robot-assisted partial nephrectomy to assess the impact of the technique on operative and postoperative outcomes. Otherwise healthy (Charlson comorbidity score ≤ 1 and bilateral kidneys) obese patients (body mass index > 30 kg/m2) with small renal masses (< 4 cm) treated from 2011 to 2015 were included in the study. The primary outcomes were intraoperative transfusion, operating time, length of hospital stay, and postoperative complications. These results show that at a high-volume center, the robot-assisted approach is associated with less blood transfusion, shorter operating time, faster recovery, and fewer perioperative complications compared with the open approach in obese patients undergoing partial nephrectomy for small renal masses.

Demographic Data and Tumor Characteristics (N = 237)

2011 – 2015

Patient Variables RAPN (N = 177) OPN (N = 60) P Value Median body mass index, kg/m2 (IQR) 33.4 (31.4 – 39) 34.1 (32.6 – 40.2) 0.16 Obesity class, N (%) 30 – 34.9 kg/m2 (class 1) 107 (60.4) 33 (55) 0.51 35 – 39.9 kg/m2 (class 2) 38 (21.5) 12 (20) ≥ 40 kg/m2 (class 3) 32 (18.1) 15 (25) Mean age, years (± SD) 54.9 (± 11.4) 55.9 (± 11.0) 0.45 Male, N (%) 105 (59.3) 30 (50.0) 0.21 Smoking status, N (%) 23 (13) 7 (11.1) 0.78 Median preoperative eGFR, mL/min/1.73m2 (IQR) 91.6 (78.2 – 101.1) 86.9 (72.8 – 102.4) 0.14 Tumor size, cm (IQR) 2.5 (2 – 3) 2.8 (2.4 – 3.1) 0.02 Multiple tumors, N (%) 11 (6.2) 2 (3.3) 0.39 Malignant tumor, N (%) 151 (85.3) 56 (93.3) 0.11 RENAL score, median (IQR) 7 (5 – 8) 7 (5 – 8) 0.36 High complexity tumor, N (%) 11 (6.2) 5 (8.3) 0.57 eGFR = estimated glomerular filtration rate, IQR = interquartile range, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy, SD = standard deviation

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108374_CCFBCH_Text_39_Rev1.pdf 1 9/19/17 12:18 PM Urology | Kidney

Primary Outcomes (N = 237)

2011 – 2015

Variables RAPN (N = 177) OPN (N = 60) P Value Median operating time, min (IQR) 180 (150 – 210) 207 (170 – 245) < 0.01 Intraoperative blood transfusion, N (%) 2 (1.1) 6 (10.0) < 0.01 Median length of stay, days (IQR) 3 (2 – 3) 4 (4 – 5) < 0.01 Overall complications: Clavien I – V, N (%) 28 (15.8) 19 (31.7) 0.01 Major complications: Clavien III – V, N (%) 10 (5.6) 1 (1.7) 0.20 IQR = interquartile range, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

Postoperative Complications in Detail (N = 237)

2011 – 2015

Complications RAPN (N = 177) OPN (N = 60) P Value Postoperative blood transfusion 4 (2.3) 3 (5) 0.27 Reoperation 2 (1.1) 0 (0) 0.40 Arrhythmia 5 (2.8) 1 (1.7) 0.62 Pneumonia 4 (2.3) 0 (0) 0.24 Deep venous thrombosis/pulmonary embolism 1 (0.6) 1 (1.7) 0.42 Ileus 4 (2.3) 1 (1.7) 0.72 Surgical site infection 2 (1.1) 7 (11.7) < 0.01 Genitourinary complications Acute kidney injury 1 (0.6) 1 (1.7) 0.44 Urine leakage 0 (0) 2 (3.3) 0.01 Urinary tract infection 0 (0) 2 (3.3) 0.01 Angioembolization 2 (1.1) 0 (0) 0.40 OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

40 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 40 8/31/17 3:14 PM Multivariable Regression Analysis for Predictors of Operating Time, Length of Stay, and Overall Complications (N = 237)

2011 – 2015

Overall Variables Operating Time Length of Stay Postoperative Complications Coefficient 95% CI P Value Coefficient 95% CI P Value Odds Ratio 95% CI P Value Age 0.32 -0.2 to 0.8 0.20 0.01 -0.01 to 0.03 0.37 1 0.9-1.0 0.44 Gender Male Reference Reference Reference Female -19.7 -32.6 to -6.7 < 0.01 -0.04 -0.5 to 0.4 0.86 0.62 0.3-1.2 0.19 Obesity Class 1 – 2 Reference Reference Reference Class 3 10.6 -5.5 to 26.7 0.19 0.7 0.08-1.30 0.02 2.35 1.0-5.1 0.03 Tumor complexity Low/moderate Reference Reference Reference High 1.19 -24.2 to 26.6 0.92 1.53 0.5-2.5 < 0.01 2.27 0.7-7.2 0.16 Tumor size 10.4 2.1-18.8 0.01 0.29 -0.02 to 0.60 0.07 1.06 0.6-7.2 0.79 Surgical approach RAPN Reference Reference Reference OPN 24.2 9.7-38.8 < 0.01 1.65 1-2.2 < 0.01 2.27 1.11-4.62 0.02 CI = confidence interval, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

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Secondary Outcomes (N = 237)

2011 – 2015

Variables RAPN (N = 177) OPN (N = 60) P Value Perioperative outcomes Median ischemia time, min (IQR) 19.5 (15 – 2.5) 27 (22 – 40) < 0.01 Warm ischemia, N (%) 158 (89.3) 11 (18.3) Cold ischemia, N (%) 5 (2.8) 36 (60) Zero ischemia, N (%) 14 (7.9) 3 (5) Median estimated blood loss, mL (IQR) 150 (75 – 210) 300 (162 – 400) < 0.01 30-day readmission, N (%) 8 (4.5) 6 (10) 0.12 Positive surgical margin, N (%) 7 (4) 2 (3.4) 0.82 Functional outcomes Median latest eGFR, mL/min/1.73m2 (IQR) 77.7 (63.8 – 91.9) 70.9 (62.6 – 88.5) 0.28 Median latest % eGFR preservation, (IQR) 83.8 (75.7 – 93.7) 85.7 (75.9 – 99) 0.43 Chronic kidney disease upstage, N (%) 34 (19.2) 11 (18.3) 0.88 Follow-up times, months (IQR) 20.9 (0.9 – 49.9) 26.1 (2.6 – 78.7) 0.09 eGFR = estimated glomerular filtration rate, IQR = interquartile range, OPN = open partial nephrectomy, RAPN = robot-assisted partial nephrectomy

Reference 1. Malkoc E, Maurice MJ, Kara O, Ramirez D, Nelson RJ, Caputo PA, Mouracade P, Stein R, Kaouk JH. Robot-assisted approach improves surgical outcomes in obese patients undergoing partial nephrectomy. BJU Int. 2017 Feb;119(2):283-288.

42 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 42 8/31/17 3:14 PM Urology | Male Fertility

Reduced Opioid Prescribing After Scrotal and Subinguinal Surgery1 Excess prescribing of opioid pain medication increases The analysis showed that a history of surgery or bilateral medical costs and the potential for abuse. Urologists have vs unilateral surgery did not affect opioid usage. Adjunct a responsibility to treat postoperative pain, but there is analgesia including nonsteroidal anti-inflammatory drugs little objective data to guide providers in procedure specific and the use of ice, scrotal support, and scrotal elevation did opioid prescribing practices. Cleveland Clinic researchers not reduce opioid use, but were used by patients instead of retrospectively analyzed opioid prescribing, usage, and additional opioids to treat increased pain. When adjuncts postoperative pain in 20 patients undergoing scrotal or were used for increased pain, they were rated favorably by subinguinal surgery and developed a pain management patients and were perceived as helpful. No combination of protocol to guide opioid and adjunct analgesia prescribing. adjuncts was significantly more beneficial than another. Results showed that a median of 20 opioid tablets As a result, current practice is to tailor opioid prescriptions were prescribed for postoperative pain but that patients to patients’ needs and, on average, no more than 4 tablets used only an average of 3.5 tablets. These data led to are initially prescribed. This standardized postoperative pain the development of a standardized protocol for pain management protocol significantly reduced the total number management after scrotal, penile, and subinguinal surgery of opioid tablets prescribed per patient from 20 to 10 that includes preoperative education, reduced opioid tablets for an average savings of $68.50 per patient. prescribing, and an emphasis on using nonopioid pain control alternatives.

Reference 1. Starks C, Zampini A, Tadros NN, McGill J, Baker K, Sabanegh ES. Reduction in opioid prescribing using a post-operative pain management protocol following scrotal and subinguinal surgery. Urol Pract. In press. doi:doi.org/10.1016/j.urpr.2017.03.010.

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Vasectomy Reversal Semen Analysis: New Reference Ranges Predict Pregnancy1 The Urological & Kidney Institute developed new semen Spontaneous pregnancy was achieved by 49.6% (69/139) analysis reference ranges to help predict pregnancy rates of patients and was directly related to better intraoperative after vasectomy reversal (VR). Previous studies have vasal fluid quality and postoperative sperm concentration, analyzed factors influencing vasal patency after VR, such as sperm motility, and strict morphology. The reference obstructive interval and vasal fluid characteristics, but few ranges for postoperative semen parameters of patients studies have addressed postoperative pregnancy outcomes. with spontaneous pregnancy were substantially lower than Center for Male Fertility researchers reviewed records of normal values published by the World Health Organization 139 patients who underwent VR from 2010 to 2014 (fifth percentile: concentration > 15 million/mL, sperm 2 to determine patient/spouse age, obstructive interval, motility > 40%, and normal morphology > 4%). intraoperative findings, procedure performed, postoperative Spontaneous pregnancy was reported in 15%, 21.3%, and semen results, and spontaneous pregnancy outcomes. 14.8% of patients with sperm concentration < 5 million/ mL, sperm motility < 10%, and normal morphology The mean obstructive interval was 9.5 ± 1.2 years. < 1%, respectively.

Semen Analysis Centiles (N = 139)

2010 – 2014

5th (95% CI) 10th 25th 50th 75th 90th 95th Volume, mL 0.74 (0.4-1.4) 1.28 1.62 2.5 3.4 4.5 5.9 Sperm concentration, million/mL 3.56 (0.1-5.89) 5.17 13.1 23.7 45.5 66.5 119.6 Total motility, % 4.45 (3-7.3) 5.9 13 25.5 37.7 54.2 63.2 Total motile count 0.58 (0.1-1.6) 0.82 4.7 14.8 42.7 92.3 152.2 Normal forms, % 0.0 (0.0-1) 1 1 3 5.75 10 14.1

These results suggest that fertility is restored in VR patients with much lower semen parameters than had previously been suggested by standard semen analysis ranges.

References 1. Majzoub A, Tadros NN, Polackwich AS, Sharma R, Agarwal A, Sabanegh E Jr. Vasectomy reversal semen analysis: new reference ranges predict pregnancy. Fertil Steril. 2017 Apr;107(4):911-915. 2. Cooper TG, Noonan E, von Eckardstein S, Auger J, Baker HW, Behre HM, Haugen TB, Kruger T, Wang C, Mbizvo MT, Vogelsong KM. World Health Organization reference values for human semen characteristics. Hum Reprod Update. 2010 May-Jun;16(3):231-345.

44 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 44 8/31/17 3:14 PM Urology | Prostate

The Center for Urologic Oncology’s prostate cancer program offers innovative, leading edge care for prostate cancer patients, including all treatment modalities for localized and locally advanced disease. Treatment options include open and robot-assisted prostatectomy, cryotherapy, and, in conjunction with the Department of Radiation Oncology, I-125 brachytherapy and Calypso®-based, image-guided, intensity-modulated external beam radiotherapy. In the outcomes graphs that follow, patient groups are defined as:1 • Low risk: Gleason score ≤ 6, clinical stage ≤ T2a, and prostate specific antigen (PSA) level < 10 ng/mL • Intermediate risk: Gleason score 7 and/or clinical stage T2b and/or PSA 10–20 ng/mL • High risk: Gleason score ≥ 8 and/or clinical stage > T2b and/or PSA > 20 ng/mL

Biochemical Relapse Free Survival of Patients With Low-Risk Prostate Cancer by Treatment Type (N = 2125) 1996 – 2016

Survival () ternal eam radioteray odoserate racyteray Years After Treatment umer at isk ternal eam radioteray odoserate racyteray

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Biochemical Relapse Free Survival of Patients With Intermediate-Risk Prostate Cancer by Treatment Type (N = 1974) 1996 – 2016

Survival () ternal eam radioteray odoserate racyteray Years After Treatment umer at isk ternal eam radioteray odoserate racyteray

Biochemical Relapse Free Survival of Patients With High-Intermediate Risk Prostate Cancer by Treatment Typea (N = 488) 1996 – 2016 Survival () ternal eam radioteray odoserate racyteray Years After Treatment umer at isk ternal eam radioteray odoserate racyteray

aHigh-intermediate risk is defined as having ≥2 intermediate risk factors.

46 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 46 8/31/17 3:14 PM Biochemical Relapse Free Survival of Patients With High-Risk Prostate Cancer by Treatment Type (N = 886) 1996 – 2016 Survival ()

ternal eam radioteray odoserate racyteray Years After Treatment umer at isk ternal eam radioteray odoserate racyteray

Reference 1. National Comprehensive Cancer Network (NCCN). Prostate Cancer. NCCN Clinical Practice Guidelines in Oncology. V.2.2007. Fort Washington, PA: NCCN; 2007. aHigh-intermediate risk is defined as having ≥2 intermediate risk factors.

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108374_CCFBCH_17OUT426_acg.indd 47 8/31/17 3:14 PM Urology | Prostate

Decipher® Genomic Classifier Predicts Metastasis Risk1 Institute researchers evaluated the ability of the Decipher genomic classifier to predict metastasis from analyses of diagnostic prostate needle biopsy tumor tissue specimens. There were 57 patients with available biopsy specimens identified from a cohort of 169 men treated with radical prostatectomy. With a median follow-up of 8 years, 8 patients experienced metastasis, and 3 died of prostate cancer. Using the Decipher test plus the National Comprehensive Cancer Network (NCCN) risk classification model had an improved C-index of 0.88 (95% CI, 0.77-0.96) compared with NCCN alone (C-index 0.75, 95% CI, 0.64-0.87).

Decipher Distribution (N = 57) 1997 – 2008 Frequency (%) 20

0 0 – 0.1 0.1 – 0.2 0.2 – 0.3 0.3 – 0.4 0.4 – 0.5 0.5 – 0.6 0.6 – 0.7 0.7 – 0.8 0.8 – 0.9 0.9 – 1.0 Biopsy Decipher Score N = 2 4 9 17 13 7 2 2 1 0

Reference 1. Klein EA, Haddad Z, Yousefi K,Lam LL, Wang Q, Choeurng V, Palmer-Aronsten B, Buerki C, Davicioni E, Li J, Kattan MW, Stephenson AJ, Magi- Galluzzi C. Decipher genomic classifier measured on prostate biopsy predicts metastasis risk. Urology. 2016 Apr;90:148-152.

48 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 48 8/31/17 3:14 PM Survival C-Index at 10 Years Post Radical Prostatectomy 1997 – 2008 Sensitivity 1.001.00

0.750.75 C-index (95% CI) Biopsy Decipher 0.8 (0.63-0.94) 0.500.50 NCCN 0.75 (0.64-0.87) NCCN + Biopsy Decipher 0.88 (0.77-0.96) 0.250.25

0.000.00 0.00 0.25 0.50 0.75 1.00 Specificity NCCN = National Comprehensive Cancer Network On multivariable analysis, Decipher was the only significant predictor of metastasis when adjusting for age, preoperative prostate specific antigen, and biopsy Gleason score (Decipher HR per 10% increase 1.72, 95% CI, 1.07-2.81,P = 0.02). Decipher predicted the risk of metastasis at 10 years post radical prostatectomy. While further validation is required on larger cohorts, preoperative knowledge of Decipher risk derived from biopsy could indicate the need for multimodality therapy and help set patient expectations of therapeutic burden.

Pretreatment Nomogram to Predict Potency After Localized Prostate Cancer Treatment Radical prostatectomy (RP), external beam radiotherapy (EBRT), and brachytherapy are commonly used treatments for localized prostate cancer and may negatively affect sexual function. Institute researchers evaluated predictors of posttreatment erectile dysfunction and developed a prognostic nomogram using prospective, patient-reported data using validated instruments. The predictive value of the nomogram may be helpful in counseling patients on posttreatment expectations. Between 1999 and 2011, patient-reported data regarding treatment related effects on erectile function were obtained from 2647 patients. Patients were treated with RP (N = 1281), EBRT (N = 625), or brachytherapy (N = 741). Patient responses were obtained at baseline and 2 years after treatment, and the end point was erectile dysfunction at 2 years posttreatment. At baseline, 1306 patients were potent and had complete data. Differences in baseline patient characteristics existed between the treatment groups. The erectile dysfunction rates at 2 years were 62%, 53%, and 41% for previously potent patients treated by RP, EBRT, and brachytherapy, respectively. Upon multivariable analysis, age, prostate specific antigen score, treatment modality, frequency of preoperative erections, diabetes, and hypertension were associated with posttreatment erectile dysfunction (all P < 0.05). A nomogram based on the predictive parameters had a C-index of 0.719, and predictions were well calibrated with observed outcomes.

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Pretreatment Characteristics (N = 2647) 1999 – 2011

Prostatectomy EBRT Brachytherapy Total Characteristic (N = 1281) (N = 625) (N = 741) (N = 2647) P Valuea Age, years (range) 61 (2 – 80) 70 (45 – 82) 67 (45 – 82) 65 (42 – 82) < 0.001 Race, N (%) < 0.001 White 1160 (90.6) 544 (87.0) 671 (90.6) 2375 (89.7) Black 53 (4.1) 60 (9.6) 41 (5.5) 154 (5.8) Other 68 (5.3) 21 (3.4) 29 (3.9) 118 (4.5) Married or 969 (75.6) 328 (52.5) 360 (48.6) 1657 (63.0) < 0.001 with partner, N (%) PSA, ng/mL (range) 5.8 (0.02 – 50) 7.0 (0 – 50) 6.0 (0.6 – 50) 6.0 (0 – 50) < 0.001 Biopsy Gleason < 0.001 score, N (%) < 7 786 (61.4) 339 (54.2) 607 (81.9) 1732 (64.4) < 7 414 (32.3) 216 (34.6) 123 (16.6) 753 (28.4) > 7 81 (6.3) 70 (11.2) 11 (1.5) 162 (6.1) Stage, N (%) < 0.001 T1 920 (71.8) 387 (61.9) 608 (82.1) 1915 (72.3) T2a 239 (18.7) 187 (29.9) 117 (15.8) 543 (20.5) T2b 79 (6.2) 35 (5.6) 9 (1.2) 123 (4.6) T2c 38 (3.0) 14 (2.2) 5 (0.7) 57 (2.2) T3 5 (0.4) 2 (0.3) 2 (0.3) 9 (0.3) Androgen deprivation therapy, N (%) 35 (2.7) 235 (37.6) 151 (20.4) 421 (15.9%) < 0.001

EBRT = external beam radiotherapy, PSA = prostate specific antigen aP value calculated by Kruskal-Wallis test for continuous variables and by chi-square test, or by Fisher exact test for categorical variables if expected frequency is less than 5 in some cells.

50 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 50 8/31/17 3:14 PM Pretreatment vs Follow-Up Erection Quality and Frequency (N = 1306a) 1999 – 2011

RP EBRT Brachytherapy Total Pretreatment Erection Qualityb, N (%) Firm enough for intercourse 795 (100) 217 (100) 294 (100) 1306 Erection Quality at 2 Years, N (%) No erection 199 (25.0) 50 (23.0) 30 (10.2) 279 (21.4) Not firm enough for any activity 127 (16.0) 16 (7.4) 29 (9.9) 172 (13.2) Firm enough for masturbation and foreplay only 151 (19.0) 38 (17.5) 50 (17.0) 239 (18.3) Firm enough for intercourse 318 (40.0) 113 (52.1) 185 (62.9) 616 (47.2) Pretreatment Erection Frequencyc, N (%) Never 10 (1.3) 24 (11.1) 20 (6.8) 54 (4.1) Less than half 15 (1.9) 3 (1.4) 5 (1.7) 23 (1.8) About half 52 (6.5) 21 (9.7) 20 (6.8) 93 (7.1) More than half 141 (17.7) 46 (21.2) 59 (20.1) 246 (18.8) At will 577 (72.6) 123 (56.7) 190 (64.6) 890 (68.1) Erection Frequency at 2 Years, N (%) Never 317 (39.9) 65 (30.0) 57 (19.4) 439 (33.6) Less than half 92 (11.6) 21 (9.7) 25 (8.5) 138 (10.6) About half 76 (9.6) 29 (13.4) 47 (16.0) 152 (11.6) More than half 132 (16.6) 30 (13.8) 42 (14.3) 204 (15.6) At will 178 (22.4) 72 (33.2) 123 (41.8) 373 (28.6)

EBRT = external beam radiotherapy, RP = radical prostatectomy aPatients with complete data bDefined as quality of erections during the previous 4 weeks cDefined as frequency of ability to get erections, when desired, during the previous 4 weeks

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Univariable Comparison of Predictors for Erectile Dysfunction 2 Years After Treatment for Localized Prostate Cancer 1999 – 2011

Predictor Potent (N = 566) Impotent (N = 719) P Valuea Androgen deprivation therapy, N (%) 34 (6.01) 63 (8.76) 0.08 Median age, years (IQR) 60.0 (55.0, 66.0) 63.0 (58.0, 68.0) < 0.001 Median prostate specific antigen, ng/mL (IQR) 5.60 (4.10, 7.20) 6.00 (4.60, 8.50) < 0.001 Median body mass index, kg/m2 (IQR) 27.0 (25.0, 30.0) 28.0 (25.0, 31.0) 0.392 Short form 12 physical component score (IQR) 57.0 (54.0, 88.0) 57.0 (53.0, 76.0) 0.078 Short form 12 mental component score (IQR) 57.0 (52.0, 61.0) 58.0 (53.0, 67.0) 0.219 Treatment, N (%) < 0.001 Brachytherapy 170 (30.0) 118 (16.4) External beam radiation therapy 102 (18.0) 114 (15.9) Radical prostatectomy 294 (51.9) 487 (67.7) Race, N (%) 0.822 Black 31 (5.5) 44 (6.1) White 18 (3.2) 20 (2.8) Other 517 (91.3) 655 (91.1) Pretreatment erection frequency score, N (%) < 0.001 Never 18 (3.2) 35 (4.9) Less than half 1 (0.2) 22 (3.1) About half 16 (2.8) 76 (10.6) More than half 83 (14.7) 159 (22.1) At will 448 (79.2) 427 (59.4) Diabetes, N (%) 23 (4.06) 58 (8.07) 0.005 Myocardial infarction, N (%) 20 (3.53) 36 (5.01) 0.252

52 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 52 8/31/17 3:14 PM Predictor Potent (N = 566) Impotent (N = 719) P Valuea Stroke, N (%) 12 (2.12) 12 (1.67) 0.7 Chronic obstructive pulmonary disease, N (%) 30 (5.30) 51 (7.09) 0.231 Depression, N (%) 40 (7.07) 63 (8.76) 0.314 Hypertension, N (%) 157 (33.2) 245 (41.8) 0.005 Gleason score, N (%) < 0.001 Low 402 (71.0) 446 (62.0) Intermediate 149 (26.3) 229 (31.8) High 15 (2.65) 44 (6.12) Clinical stage, N (%) 0.541 T1 426 (75.3) 525 (73.0) T2a 112 (19.8) 145 (20.2) T2b 18 (3.18) 33 (4.59) T2c – T3 10 (1.77) 16 (2.23) Median prostate volume, cc (IQR) 38 (30, 50) 40 (31, 53) 0.017

a P value calculated by nonparametric Wilcoxon rank-sum test for continuous variables, and by chi-square test, or Fisher exact test if expected frequency is less than 5 in some cells, for categorical variables.

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108374_CCFBCH_17OUT426_acg.indd 53 8/31/17 3:14 PM Urology | Prostate

Multivariable Analysis — Prediction of Erectile Dysfunction 2 Years After Treatment for Localized Prostate Cancer 1999 – 2011

Factor Q1 Q3 Odds Ratioa 95% Lower 95% Upper P Value Age, years 57 67 1.99 1.64 2.40 < 0.0001 Prostate specific antigen, ng/mL 4.38 8 1.18 1.07 1.30 0.0005 Treatment Brachytherapy Reference External beam radiation therapy n/a n/a 1.07 0.71 1.60 0.7501 Radical prostatectomy n/a n/a 3.9 2.81 5.42 < 0.0001 Gleason score group Low Reference Intermediate n/a n/a 1.10 0.84 1.44 0.4992 High n/a n/a 1.80 0.93 3.50 0.0815 Pretreatment erection frequencyb Never – less than half Reference About half n/a n/a 1.43 0.66 3.11 0.3635 More than half n/a n/a 0.58 0.31 1.06 0.0775 At will n/a n/a 0.30 0.17 0.53 < 0.0001 Diabetes n/a n/a 2.09 1.20 3.62 0.0089

aContinuous predictors were modeled as restricted cubic splines and the odds ratios were given as change from first quartile to third quartile. bErection frequency defined as frequency of ability to obtain erections adequate for intercourse, when desired, during previous 4 weeks.

54 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 54 8/31/17 3:14 PM Nomogram Predicting Risk of Erectile Dysfunction 2 Years After Localized Prostate Cancer Treatment 0102030405060708090 100 Points

EBRT Treatment Brachytherapy RP

Age 40 45 50 55 60 7065 75 80 85

Intermediate Gleason Score Low High

PSA 03105 15 20 53025 40 45 50

4 3 Preoperative Erection Frequency Level 5 1-2 Yes Diabetes No

Total Points 020406080 100 120 140 160 180 200 220 240

Risk of Impotency at 24-Month Follow-up 0.1 0.3 0.5 0.7 0.9 0.95

EBRT = external beam radiotherapy, PSA = prostate specific antigen, RP = radical prostatectomy

Reference 1. Zabell J, Sands MG, Litewin MS, Suarez JF, Regan MM, Saigal C, Kwan L, Gao T, Rabah D, Klein EA, Kattan MW, Stephenson AJ. Pre- treatment nomogram to predict potency after treatment for localized prostate cancer. J Clin Oncol. 2016 Jan;34(Suppl 2S):abstr 32. DOI: 10.1200/jco.2016.34.2_suppl.32

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The Effect of Prostatectomy Technique on Genitourinary Toxicity1 The institute conducted an inception cohort study to assess the association of genitourinary (GU) toxicity with prostatectomy technique: open radical prostatectomy (RP), pure laparoscopic RP, and robotic-assisted laparoscopic RP. The primary end point was grade 3 or greater GU toxicity. There were 1308 patients in the study, with a median follow-up of 55.6 months. Patients were segregated into the 3 cohorts as follows: 732 open RP, 103 laparoscopic RP, and 473 robotic RP. There was no significant difference between the 3 techniques P( = 0.6). The most common toxicities were urinary obstruction (54.8% of all toxicities) and urinary incontinence (33.3% of all toxicities). Of the patients with a grade 3 or higher toxicity, 85% were grade 3.

Descriptive Statistics for High-Risk Radical Prostatectomy Patients (N = 1308) 1996 – 2012

All Patients Laparoscopic RP Robotic RP Open RP N/Median %/Range N/Median %/Range N/Median %/Range N/Median %/Range P Value Number of patients 1308 100 103 7.9 473 36.2 732 56.0 Age, years 62 43 – 79 63 45 – 75 63 44 – 78 61.5 43 – 79 0.0285 Risk 2 intermediate 582 44.5 47 45.6 223 47.1 312 42.6 factors ≥ 1 high-risk factor 725 55.5 56 54.4 250 52.9 420 57.4 Clinical stage < 0.0001 T1 or T2a 779 59.6 86 83.5 269 56.9 424 57.9 T2b or T2c 489 37.4 17 16.5 194 41.0 278 38.0 T3 40 3.1 0 0.0 10 2.1 30 4.1 Initial PSA (ng/mL) 0.0004 < 4 134 10.2 4 3.9 58 12.3 72 9.8 4 – 10 527 40.3 38 36.9 219 46.3 270 36.9 11 ≤ 19 451 34.5 44 42.7 142 30.0 265 36.2 ≥ 20 196 15.0 17 16.5 54 11.4 125 17.1

PSA = prostate specific antigen, RP = radical prostatectomy

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108374_CCFBCH_17OUT426_acg.indd 56 8/31/17 3:14 PM All Patients Laparoscopic RP Robotic RP Open RP N/Median %/Range N/Median %/Range N/Median %/Range N/Median %/Range P Value Biopsy Gleason score 0.2294 6 70 5.4 5 4.9 17 3.6 48 6.6 7 662 50.6 56 54.4 243 51.4 363 49.6 8 – 10 576 44.0 42 40.8 213 45.0 321 43.9 Neoadjuvant therapy < 0.0001 No 1061 81.1 87 84.5 448 94.7 526 71.9 Yes 247 18.9 16 15.5 25 5.3 206 28.1 Years of treatment < 0.001 1996 – 2000 208 15.9 3 2.9 0 0.0 205 28.0 2001 – 2004 213 16.3 54 52.4 2 0.4 157 21.4 2005 – 2008 347 26.5 45 43.7 119 25.2 183 25.0 2009 – 2012 540 41.3 1 1.0 352 74.4 187 25.5 Postoperative RT 0.0258 No/unknown 1065 81.4 90 87.4 397 83.9 578 79.0 Yes 243 18.6 13 12.6 76 16.1 154 21.0 Follow-up time, years 4.6 0.01 – 19.9 5.2 0.01 – 12.9 3.3 0.02 – 10.5 6.5 0.01 – 19.9 < 0.001 Grade ≥ 3 GU toxicity No 1007 77.0 80 77.7 409 86.5 518 70.8 Yes 158 12.1 12 11.7 41 8.7 105 14.3 Dead without toxicity 143 10.9 11 10.7 23 4.9 109 14.9

GU = genitourinary, RP = radical prostatectomy, RT = radiotherapy - continued

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Descriptive Statistics for High-Risk Radical Prostatectomy Patients (N = 1308) - continued 1996 – 2012

All Patients Laparoscopic RP Robotic RP Open RP N/Median %/Range N/Median %/Range N/Median %/Range N/Median %/Range P Value Grade ≥ 3 GU toxicities Anastomotic leak 1 0.6 0 0.0 0 0.0 1 1.0 Fistula 6 3.8 0 0.0 2 4.9 4 3.8 Hernia 2 1.3 0 0.0 1 2.4 1 1.0 Incontinence 47 29.7 8 66.7 12 29.3 27 25.7 Infection 12 7.6 0 0.0 4 9.8 8 7.6 Necrotic tissue 1 0.6 0 0.0 1 2.4 0 0.0 Obstruction 75 47.5 3 25.0 16 39.0 56 53.3 Pain 1 0.6 1 8.3 0 0.0 0 0.0 Renal failure 1 0.6 0 0.0 0 0.0 1 1.0 RT cystitis 9 5.7 0 0.0 4 9.8 5 4.8 Spermatocele 1 0.6 0 0.0 1 2.4 0 0.0 Testicular infarct 1 0.6 0 0.0 0 0.0 1 1.0 Urgency 1 0.6 0 0.0 0 0.0 1 1.0

GU = genitourinary, PSA = prostate specific antigen, RP = radical prostatectomy, RT = radiotherapy

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108374_CCFBCH_17OUT426_acg.indd 58 8/31/17 3:14 PM Cumulative Incidence for Grade ≥3 Genitourinary Toxicity (Excluding Secondary Malignancies) by RP Technique 1996 – 2012

Treatment Laparoscopic RP Robot-Assisted RP Open RP Number of Patients 103 473 732 1-yr Number at risk 73 359 634 Cumulative incidence 6.8 3.5 6.8 95% CI (%) 1.5 – 12.1 1.8 – 5.3 4.9 – 8.6 5-yr Number at risk 47 106 405 Cumulative incidence 9.2 11.3 13.8 95% CI (%) 3.1 – 15.3 7.9 – 14.8 11.2 – 16.5 10-yr Number at risk 14 3 206 Cumulative incidence 16.6 15.5 17.1 95% CI (%) 6.5 – 26.2 8.1 – 22.9 14.0 – 20.2 15-yr Number at risk 0 0 64 Cumulative incidence n/a n/a 17.6 95% CI (%) n/a n/a 14.4 – 20.9

Percent 100 Laparoscopic RP Overall, toxicities were mild and 80 Robotic RP were not different between the Open RP 60 3 RP techniques. Within the P = 0.6028 40 first 3 years, robot-assisted RP patients had fewer events, but 20 this difference vanished with 0 further follow-up. 01234567 8910 11 12 13 14 15 16 17 18 19 20 Years

RP = radical prostatectomy

Reference 1. Ciezki JP, Reddy CA, Haber GP, Kaouk J, Stephenson AJ, Berglund RK, Klein EA. The effect of prostatectomy technique on genitourinary toxicity. J Clin Oncol. 2017 Feb;35(Suppl 6S):abstr 100. DOI: 10.1200/JCO.2017.35.6_suppl.100

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Genomic Prostate Score as a Predictor of Recurrence in Intermediate- and High-Risk Prostate Cancer1 The institute studied whether the 17 gene genomic prostate score (GPS) is an independent predictor of biochemical recurrence (BCR) and clinical recurrence (CR) in higher risk prostate cancer. Data from a prior development study of radical prostatectomies in 441 men with American Urological Association (AUA) low-, intermediate- and high-risk disease were analyzed.2 Broad, overlapping ranges of GPS values were observed across all AUA risk groups. A GPS of 20 units (scale 0–100) was strongly associated with BCR (HR 1.64, P < 0.001, q-value < 0.1%) and CR (HR 2.79, P < 0.001, q-value < 0.1%), after adjusting for AUA risk group. Intermediate-risk patients with a GPS > 40, who represented 41% of all intermediate-risk patients, had estimated 3-year BCR and 10-year CR risks similar to those seen in high-risk patients.

Rapid Metastasis-Corrected, 3-Year Biochemical Recurrence Risk and 10-Year Clinical Recurrence Risk for Intermediate- and High-Risk Patients (N = 206) 1997 – 2011

Intermediate Risk (N = 104) High Risk (N = 102) GPS Group N, % BCR Risk, % CR Risk, % N, % BCR Risk, % CR Risk, % GPS ≤ 40 59 15.7 4.7 63 23.8 8.5 GPS > 40 41 33.5 16.9 37 47.8 34.9 All 100 22.7 9.6 100 32.9 18.2

BCR = biochemical recurrence, CR = clinical recurrence, GPS = genomic prostate score

Conversely, high-risk patients with a GPS ≤ 40, who represented 63% of all high-risk patients, had a 3-year BCR risk and a 10-year CR risk similar to those of men with intermediate-risk disease. High-risk patients with a GPS > 40 had a 3-year BCR risk of almost 50% and a 10-year CR risk of 35%. If these findings are confirmed in an independent cohort, GPS may provide improved risk stratification for BCR and CR in AUA intermediate- and high-risk prostate cancer.

References 1. Klein EA, Zhang N, Crager M, Maddala T, Febbo PG, Thomas S, Gormley M, Sokol Ricci D, Moscovita Falzarano S, Magi-Galluzzi C, Lawrence HJ. A 17-gene genomic prostate score (GPS) as a predictor of biochemical (BCR) and clinical recurrence (CR) in men with surgically treated intermediate- and high-risk prostate cancer (PCa). J Clin Oncol. 2016 Jan;34(Suppl 2S):abstr 104. DOI: 10.1200/jco.2016.34.2_suppl.104 2. Klein EA, Cooperberg MR, Maggi-Galluzzi C, Simko JP, Falzarano SM, Maddala T, Chan JM, Li J, Cowan JE, Tsiatis AC, Cherbavaz DB, Pelham RJ, Tenggara-Hunter I, Baehner FL, Knezevic D, Febbo PG, Shak S, Kattan MW, Lee M, Carroll PR. A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy undersampling. Eur Urol. 2014 May;66(3):550-560.

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108374_CCFBCH_17OUT426_acg.indd 60 8/31/17 3:14 PM Comorbid Disease Burden Is Independently Associated Descriptive Statistics for High-Risk Radical Prostatectomy Patients (N = 1308) continued With Higher Risk Disease at Prostatectomy in Patients 1996 – 2012 Eligible for Active Surveillance1 Institute researchers studied the association between comorbidity burden and higher risk disease among men with prostate cancer eligible for active surveillance. The study sample included 29,447 cases, identified from the National Cancer Database, of low-risk (Gleason score ≤ 6, T1/T2a, prostate specific antigen [PSA] < 10 ng/mL) prostate cancer managed with prostatectomy from 2010 to 2011. The primary outcome was pathologic upgrading (Gleason score > 6) or up staging (T3–T4/N1). The association between Charlson comorbidity index score and upgrading/upstaging was analyzed. A total of 449 (1.5%) men had Charlson scores > 1. At prostatectomy, 44% of cases were upgraded/upstaged. On multivariate analysis, Charlson score > 1, age ≥ 70 years, nonwhite race, higher PSA, and higher percentage of disease- involved cores were significantly associated with upgrading/ upstaging. After further adjusting for age, race, PSA, and core involvement, Charlson score remained a significant predictor of upgrading/upstaging for younger white men. Specifically, white men < 70-years-old with a Charlson score > 1 had increased risk of upgrading/upstaging than men with a Charlson comorbidity index score ≤ 1 (OR 1.31, 95% CI 1.03-1.67, P = 0.029).

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Patient Characteristics (N = 29,447) 2010 – 2011

Charlson Comorbidity Charlson Comorbidity Index ≤ 1 Index > 1 P Value Clinical Characteristics Age, years < 0.001 Mean (range) 59.5 (33 – 90) 61.8 (41 – 76) Median (IQR) 60.0 (55, 65) 62.0 (57, 67) Race, N (%) < 0.001 White 23,874 (82.3) 313 (69.7) Other 5124 (17.7) 136 (30.3) Demographic Characteristics Income level, N (%) < 0.001 Low 2638 (9.55) 76 (17.5) Low middle 4215 (15.3) 82 (18.9) Middle 7415 (26.8) 124 (28.5) Upper middle 13,361 (48.4) 1563 (35.2) County, N (%) 0.372 Urban 4257 (15.5) 65 (15.1) Metropolitan 22,529 (82.1) 353 (82.1) Rural 651 (2.37) 12 (2.79) Preoperative Characteristics T stage, N (%) 0.536 1 26,314 (90.7) 412 (91.8) 2 2684 (9.26) 37 (8.24) PSA (ng/mL) 0.062 Mean (range) 5.0 (0.1 – 9.9) 5.2 (0.1 – 9.9) Median (IQR) 4.8 (3.9, 6.0) 5.0 (4.1, 6.5) Positive cores (%) 0.595 Mean (range) 30.3 (1 – 100) 29.7 (5 – 100) Median (IQR) 25.0 (13, 42) 25.0 (13, 42)

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108374_CCFBCH_17OUT426_acg.indd 62 8/31/17 3:14 PM Multivariate Analysis of Factors Associated With Upgrading and/or Upstaging at Prostatectomy (N = 29,447) 2010 – 2011

OR 95% CI P Value Age, years < 0.001 < 70 1.0 (referent) ≥ 70 1.32 1.20 – 1.45 Charlson comorbidity index 0.002 ≤ 1 1.0 (referent) > 1 1.35 1.11 – 1.64 Race 0.001 White 1.0 (referent) Nonwhite 1.12 1.05 – 1.19 Income level 0.511 Low 1.0 (referent) Low middle 0.94 0.85 – 1.03 Middle 0.98 0.90 – 1.08 Upper middle 0.98 0.89 – 1.07 County 0.271 Urban 1.0 (referent) Metropolitan 0.95 0.88 – 1.02 Rural 1.04 0.88 – 1.23 Clinical T stage 0.982 1 1.0 (referent) 2a 1.0 0.92 – 1.09 PSA (ng/mL) < 0.001 < 4 1.0 (referent) ≥ 4 1.66 1.57 – 1.76 Positive cores, % < 0.001 < 33 1.0 (referent) 33 – 67 1.51 1.43 – 1.61 > 67 1.50 1.35 – 1.67

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Multivariate Analysis of Factors Associated With Upgrading and/or Upstaging at Prostatectomy by Age and Race Groups (N = 29,447) 2010 – 2011

Age < 70, White Age < 70, Nonwhite Age ≥ 70, White Age ≥ 70, Nonwhite (N = 22,487) (N = 4985) (N = 1700) (N = 275) OR (95% CI) P Value OR (95% CI) P Value OR (95% CI) P Value OR (95% CI) P Value Charlson 0.029 0.119 0.229 0.998 comorbidity index ≤ 1 1.00 1.00 1.00 1.00 (referent) (referent) (referent) (referent) > 1 1.31 1.33 1.49 1.00 (1.03-1.67) (0.93-1.92) (0.78-2.83) (0.32-3.10) PSA (ng/mL) < 0.001 < 0.001 < 0.001 0.122 < 4 1.00 1.00 1.00 1.00 (referent) (referent) (referent) (referent) ≥ 4 1.67 1.67 1.95 1.66 (1.57-1.77) (1.46-1.91) (1.51-2.52) (0.87-3.17) Positive cores, % < 0.001 < 0.001 < 0.001 0.383 < 33 1.00 1.00 1.00 1.00 (referent) (referent) (referent) (referent) 33 – 67 1.54 1.42 1.60 1.39 (1.44-1.65) (1.23-1.63) (1.26-2.05) (0.74-2.61) > 67 1.48 1.37 1.60 1.69 (1.32-1.67) (1.07-1.75) (1.04-2.46) (0.63-4.50)

Comorbidity burden is strongly and independently associated with pathologic upgrading/upstaging in men with clinically low-risk prostate cancer. This finding may help improve disease risk assessment and clinical decision making in men with comorbidities considering active surveillance.

Reference 1. Maurice MJ, Zhu H, Kiechle JE, Kim SP, Abouassaly R. Comorbid disease burden is independently associated with higher risk disease at prostatectomy in patients eligible for active surveillance. J Urol. 2016 Apr;195(4 Pt 1):919-924.

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108374_CCFBCH_17OUT426_acg.indd 64 8/31/17 3:14 PM Dose-Escalated Stereotactic Body Radiation Therapy for Patients With Intermediate- and High-Risk Prostate Cancer Patients with intermediate- and high-risk prostate cancer were treated to a minimum dose of 36.25 Gy in 5 factions, with a simultaneous dose escalation to a dose of 50 Gy to the target volume away from a high-dose avoidance zone. Acute and late onset genitourinary and gastrointestinal toxicity outcomes were measured according to the 5-point (0-4) National Cancer Institute Common Terminology Criteria for Adverse Events toxicity scale, version 4.1

Acute Treatment-Related Adverse Events by Toxicity Type and Grade (N = 24) 2011 – 2014

Toxicities () 100 CTCAE Toxicity Grade 80 0 1 60 2 40 20 0 0 0 0 0 0 0 atigue Diarrhea Proctitis Urinary Dysuria Urinary Urinary freuency incontinence retention

CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events toxicity scale, version 4.

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Late-Onset Treatment-Related Adverse Events by Toxicity Grade (N = 24) 2011 – 2014

Toxicities (%) 8 CTCAE Toxicity Grade 0 6 1 2 4

2 00 00 0 0 Cystitis Urinary Frequency Proctitis (noninfective) Type of Toxicity

CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events toxicity scale, version 4.

Acceptably low rates of acute (< 90 days after treatment) and long-term (> 90 days after treatment) genitourinary and gastrointestinal toxicity can be achieved in patients with intermediate and high-risk prostate cancer treated without sacrificing biochemical control with stereotactic body radiation therapy.

Reference 1. Kotcha R, Djemil T, Tendulark Rd, Reddy CA, Thousand RA, Vassil A, Stovsky M, Berglund RK, Klein EA, Stephans KL. Dose-escalated stereotactic body radiation therapy for patients with intermediate- and high-risk prostate cancer: initial dosimetry analysis and patient outcomes. Int J Radiat Oncol Biol Phys. 2016 Jul 1;95(3):960-964.

66 Outcomes 2016

108374_CCFBCH_Text_65-67_Rev1.pdf 2 9/19/17 12:18 PM Long-Term Efficacy and Toxicity of Low-Dose-Rate 125I Prostate Brachytherapy as Monotherapy in Prostate Cancer A large cohort of prostate brachytherapy patients were followed up prospectively since the beginning of brachytherapy treatment at Taussig Cancer Institute.1 Patients were treated with 125I brachytherapy as monotherapy up to 144 Gy.

Biochemical Relapse Free Survival in Prostate Cancer Patients Treated With Low-Dose-Rate 125I Prostate Brachytherapy by Risk Group (N = 1760) 1996 – 2007

Biochemical Relapse Free Survival () 100100 o s 102 otemete s 20 00 temete s 1 6060 s 00 2020 00 0 10 1 ears After Treatment e 10e tets t u tets t u tets s s 160 102 1 16 1 0 o s 102 00 12 6 06 otemete s 20 1 00 2 1 temete s 1 0 10 s 2 6 6

CI = confidence interval aLow-intermediate risk is defined as having only one intermediate risk factor. bHigh-intermediate risk is defined as having ≥ 2 intermediate risk factors.

Reference 1. Kittel JA, Reddy CA, Smith KL, Stephans KL, Tendulkar RD, Ulchaker J, Angermeier K, Campbell K, Stephenson A, Klein EA, Wilkinson DA, Ciezki JP. Long-term efficacy and toxicity of low-dose-rate 125I prostate brachytherapy as monotherapy in low-, intermediate-, and high risk prostate cancer. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):884-893.

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Distant Metastases Free Survival in Prostate Cancer Patients Treated With Low-Dose-Rate 125I Prostate Brachytherapy by Risk Group (N = 1760) 1996 – 2007

Distant Metastases Free Survival () o risk ointermediate riska igintermediate risk ig risk Years After Treatment ear ear atients at urial atients at urial atients isk I isk I ll o risk ointermediate risk igintermediate risk ig risk

CI = confidence interval aLow-intermediate risk is defined as having only one intermediate risk factor. bHigh-intermediate risk is defined as having ≥ 2 intermediate risk factors.

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108374_CCFBCH_17OUT426_acg.indd 68 8/31/17 3:14 PM Overall Survival in Prostate Cancer Patients Treated With Low-Dose-Rate 125I Prostate Brachytherapy by Risk Group (N = 1989) 1996 – 2007

Survival () o risk ointermediate riska igintermediate risk ig risk Years After Treatment ear ear atients at urial atients at urial atients isk I isk I ll o risk ointermediate risk igintermediate risk ig risk

CI = confidence interval aLow-intermediate risk is defined as having only one intermediate risk factor. bHigh-intermediate risk is defined as having ≥ 2 intermediate risk factors.

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Cumulative Incidence of Prostate Cancer Specific Mortality in Patients Treated With Low-Dose-Rate 125I Prostate Brachytherapy by Risk Group (N = 1989) 1996 – 2007

Cumulative Mortality () o risk ointermediate riska igintermediate risk ig risk

Years After Treatment ear ear atients at urial atients at urial atients isk I isk I ll o risk ointermediate risk igintermediate risk ig risk

CI = confidence interval aLow-intermediate risk is defined as having only one intermediate risk factor. bHigh-intermediate risk is defined as having ≥ 2 intermediate risk factors.

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108374_CCFBCH_17OUT426_acg.indd 70 8/31/17 3:14 PM Late Grade ≥3 Gastrointestinal Toxicity in Patients Treated With Low-Dose-Rate 125I Prostate Brachytherapy (N = 1989) 1996 – 2007

Toxicity () G

CTACE = National Cancer Institute common terminology criteria for adverse events toxicity scale, version 4, RTOG = Radiation Therapy Oncology Group Years

Late Grade ≥3 Genitourinary Toxicity in Patients Treated With Low-Dose-Rate 125I Prostate Brachytherapy (N = 1989) 1996 – 2007

Toxicity (%) 30 CTACE RTOG 20

10 CTACE = National Cancer Institute common terminology criteria for adverse events toxicity scale, version 4, 0 RTOG = Radiation Therapy Oncology Group 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Years

Overall, results show that prostate brachytherapy is effective and has low rates of late toxicity when performed as monotherapy.

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A large cohort of patients with stage T1-T2Nx M0 low- and intermediate-risk prostate cancer who underwent low-dose-rate permanent prostate brachytherapy (PPB) with 125I was followed up prospectively in a registry to determine the efficacy and toxicity of PPB based on prostate size.1

Biochemical Relapse Free Survival in Patients With Stage T1a-T2Nx M0 Low- and Intermediate-Risk Prostate Cancer Treated with Permanent Prostate Brachytherapy Alone Without Androgen Deprivation Therapy by Gland Volume (N = 2076) 1996 – 2012 Biochemical Relapse Free Survival (%) 100 >60 CC (N = 269) 80 ≤60 CC (N = 1807) P value = 0.0175 60 40 20 0 01 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Years After Treatment > 66 CC 269 240 198 153 116 92 68 45 26 18 7 4 2 1 1 ≤ 66 CC 1802 1577 1259 962 717 501 348 229 149 86 51 30 15 6 1

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108374_CCFBCH_17OUT426_acg.indd 72 8/31/17 3:14 PM Late Grade ≥3 Genitourinary Toxicity in Patients With Stage T1a-T2Nx M0 Low- and Intermediate-Risk Prostate Cancer Treated with Permanent Prostate Brachytherapy Alone Without Androgen Deprivation Therapy by Gland Volume (N = 2076) 1996 – 2012 Toxicity (%) 30 >60 CC (N = 269) ≤60 CC (N = 1807) 20 P value = 0.0007

0 01 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Years After Treatment > 66 CC 269 238 201 166 140 118 83 64 34 21 10 4 1 1 1 ≤ 66 CC 18071622 1340 1079 887 693 499 365 237 146 90 58 34 18 9 Long-term data indicate PPB implantation of large prostates > 60 cc results in favorable bRFS outcomes and is associated with increased, but acceptable, rates of Grade 3 and higher late genitourinary toxicities. Reference 1. Pham YD, Kittel JA, Reddy CA, Ciezki JP, Klein EA, Stephans KL, Tendulkar RD. Outcomes for prostate glands > 60 cc treated with low-dose-rate brachytherapy. Brachytherapy. 2016 Mar-Apr;15(2):163-168.

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Cumulative Mortality Due to Prostate Cancer of Patients With Low-Risk Prostate Cancer by Treatment Typea (N = 2125) 1996 – 2016 Cumulative Mortality (%) 100 External beam radiotherapy (N = 501) 80 Low-dose-rate brachytherapy (N = 1624) 60 40 20 0 0 5 10 15 20 Years After Treatment Mortality Rates (Number of Patients) External beam radiotherapy 0.9 (381) 1.7 (208) 3.1 (36) Low-dose-rate brachytherapy 0.3 (918) 2.1 (223) 2.4 (27)

Cumulative Mortality Due to Prostate Cancer of Patients With Intermediate-Risk Prostate Cancer by Treatment Typea (N = 1974) 1996 – 2016 Cumulative Mortality (%) 100 External beam radiotherapy (N = 520) 80 Low-dose-rate brachytherapy (N = 1454) 60 40 20 0 0 5 10 15 20 Years After Treatment Mortality Rates (Number of Patients) External beam radiotherapy 2.0 (359) 5.0 (181) 8.5 (19) Low-dose-rate brachytherapy 0.2 (550) 2.5 (86) 8.2 (5)

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108374_CCFBCH_17OUT426_acg.indd 74 8/31/17 3:14 PM Cumulative Mortality Due to Prostate Cancer of Patients With High-Intermediate Risk Prostate Cancer by Treatment Typea,b (N = 488) 1996 – 2016 Cumulative Mortality (%) 100 External beam radiotherapy (N = 232) 80 Low-dose-rate brachytherapy (N = 256) 60 40 20 0 0 5 10 15 20 Years After Treatment Mortality Rates (Number of Patients) External beam radiotherapy 2.9 (178) 5.1 (96) 9.7 (31) Low-dose-rate brachytherapy 2.1 (103) 2.1 (21) 2.1 (2)

bHigh-intermediate risk is defined as having ≥2 intermediate risk factors

Cumulative Mortality Due to Prostate Cancer of Patients with High Risk Prostate Cancer by Treatment Typea (N = 886) 1996 – 2016 Cumulative Mortality (%) 100 External beam radiotherapy (N = 588) 80 Low-dose-rate brachytherapy (N = 298) 60 40 20 0 0 5 10 15 20 Years After Treatment Mortality Rates (Number of Patients) External beam radiotherapy 6.2 (409) 14.6 (207) 21.8 (44) Low-dose-rate brachytherapy 3.8 (126) 5.3 (22) 5.3 (1)

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Urethral Stricture Repair Related to Hypospadias

Institute urologists have extensive experience in the Stricture Location (N = 51) treatment of urethral stricture disease, including 2002 – 2014 management of complex strictures such as those in adults with a history of hypospadias. Percent 100 From 2002 to 2014, 51 hypospadias patients underwent urethral stricture repair with a staged approach using oral 80 mucosa, which institute surgeons prefer for the majority of 60 these cases. A total of 50 of the patients have completed all 40 stages of the repair. 20 0 Penile Panurethral

A majority (87%) of patients had undergone prior open repair, with many (41%) having had 2 or more previous repairs. During the first stage, the median length of buccal mucosal graft(s) required was 7 cm, which correlated with stricture length. Approximately 25% of patients experienced complications including wound separation, infection, stricture recurrence, and bleeding, most of which were relatively minor. Eight patients (16%) required a revision procedure, including

Retrograde urethrogram for a 48-year-old male with a history of childhood urethral meatal improvement, urethrocutaneous fistula hypospadias repair and multiple subsequent dilations, showing severe repair, and repeat urethroplasty. At a median follow-up stricture and distal urethral fistula of 17 months, almost all patients (98%) were able to Oral mucosa is widely accepted as the first choice void without obstructive symptoms. material for urethral substitution and is associated with high rates of graft success and healing. Oral mucosa is most often harvested from the inner cheeks, and occasionally from the lingual region for the second stage procedure. When necessary and if available, genital skin can also be incorporated into the repair. The institute recommends waiting 4–6 months between the first and second stages to allow for maturation, vascularization, and softening of the graft.

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108374_CCFBCH_17OUT426_acg.indd 76 8/31/17 3:14 PM First stage buccal graft urethroplasty in a 31-year-old Second stage closure in a 38-year-old male with a history male, status post hypospadias surgery with mid-shaft of multiple childhood hypospadias procedures and recurrent urethral stricture and urethral hair. stricture with urinary retention.

Stricture length, location, and prior surgical history did not affect surgical outcomes. Based on these results, patients with complex urethral stricture disease related to hypospadias with associated prior repairs have a high rate of successful reconstruction with staged oral mucosa graft urethroplasty.

Penile Prostheses in Solid Organ Transplant Recipients

Solid organ transplantation, with its associated Peripheral vascular disease, stroke, and diabetes were immunosuppression, has generally been considered a more common in the transplant patients. There were no relative contraindication to penile prosthesis placement significant differences in reoperation rates based on type due to a perceived increased risk of complications. of organ transplanted or between patients with or without Glickman Urological & Kidney Institute urologists have organ transplant. There were no differences in reoperation extensive experience in prosthesis implantation in difficult rate by implant model (2-piece vs 3-piece) used. or challenging patient populations, including those with a Penile prosthesis implantation outcomes in transplant history of transplantation. patients do not differ from those in nontransplant patients, From 1999 to 2015, 26 patients with a history of heart, and 2-piece and 3-piece implants have similar outcomes in liver, kidney, and kidney-pancreas transplants underwent these patients. The results indicate that penile prostheses penile prosthesis implantation. Outcomes were compared are a safe option for treating erectile dysfunction in solid with an age-matched nontransplant penile implant cohort. organ transplant recipients. There were no cases of prosthesis infection in either group.

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Penile Prosthesis Implantation Outcomes in Patients With and Without Solid Organ Transplant (N = 26)

1999 – 2015

Transplant + Prosthesis Prosthesis Alone P Value Age, years 53.7 56.4 0.26 Body mass index, kg/m2 30.3 30.2 0.92 Reoperation rate, % 7.7 11.5 1.00 Prosthesis infection rate, % 0.0 0.0 1.00 Prior history of, % Prostate surgery 7.7 15.4 0.39 Rectal surgery 3.9 3.9 1.00 Hyperlipidemia 69.2 69.2 1.00 Hypertension 92.3 76.9 0.25 Heart disease 57.5 30.8 0.09 Peripheral vascular disease 26.9 3.9 0.02 Stroke 19.2 0.0 0.05 Diabetes 84.6 53.6 0.02

Reoperation Rate by Implant Model for Penile Prosthesis in Patients With and Without Solid Organ Transplant (N = 26)

1999 – 2015 Percent 15 2-piece prosthesis 3-piece prosthesis 10

0 Transplant + Penile Penile Prosthesis Prosthesis Alone

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108374_CCFBCH_17OUT426_acg.indd 78 8/31/17 3:14 PM Institute Quality Improvement Initiatives

Glickman Urological & Kidney Institute is committed to continuous quality and patient safety improvement, and to ensuring that patients receive optimal care. The following performance measurements are examples of the institute’s areas of focus and results. Patient Safety Indicators Patient safety indicators (PSIs) were developed by the Agency for Healthcare Research and Quality primarily for quality improvement purposes. They are coded based on documentation in the medical record, are publicly reported, and are used to compare hospital performance. PSIs are potentially avoidable complications and iatrogenic events occurring during hospitalizations. The Urological & Kidney Institute quality review team works closely with front-line care providers and staff, ensuring case review of each PSI and timely provider feedback to sustain improvement. The PSI 90 measure is a weighted composite of 10 patient safety indicators. Since 2012, the institute has achieved a 64% reduction in the total number of PSI 90 occurrences. This was accomplished through a combination of improved clinical performance and diligent educational and documentation improvement initiatives.

Patient Safety Indicator: Occurrences 2012 – 2016 Number 80

0 2012 2013 2014 2015 2016

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Hospital Readmission The Centers for Medicare & Medicaid Services’ Hospital Readmissions Reduction Program focuses on reducing preventable, expensive, and excessive 30- day hospital readmissions among patients with acute myocardial infarction, pneumonia, heart failure, chronic obstructive pulmonary disease, total hip/ knee replacement surgery, and coronary artery bypass graft surgery. The Urological & Kidney Institute has devoted process improvement efforts to reduce readmissions for these conditions and for all cause 30-day readmissions. The quality improvement team reviews monthly readmissions to identify trends offering opportunities for improvement. Readmission reduction efforts have primarily involved engaging patients and improving communication between patients and care providers, focusing on medication reconciliation, enhanced patient and caregiver education, completion of discharge summaries within 48 hours of discharge, and timely follow-up appointments after discharge. Since 2012, urology readmissions have decreased by 17%.

Readmission: All Cause 30-Day

2011 – 2016 Percent 20 Urology Cleveland Clinic targeta 15

0 2011 2012 2013 2014 2015 2016 Nb = 2263 2458 2315 2132 2029 1931

aCleveland Clinic began implementing a readmission target in 2013. bNumber of discharges

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Increasing Safe Discharge Efficiency for Urology Unit Patients With increasing patient numbers, demand for hospital beds sometimes exceeds capacity, leading to delays in patient transfer, hospital readmissions, postanesthesia care unit overcrowding, and patient dissatisfaction. The Joint Commission, acknowledging the importance of patient flow, emphasizes that hospitals measure bed supply and the efficiency of patient care areas, report measurements to leadership, and use data to drive improvements in patient flow processes.1 The complex inpatient discharge process, which requires the collaboration of physicians, nurses, patients, care managers, pharmacists, and ancillary service staff, represents an opportunity to address patient flow efficiency while involving all parties who participate in patient care. To this end, the institute formed a resident-led team to identify and improve discharge efficiency. A retrospective review of elective renal surgery patients identified as having routine hospital stays from May 2016 to October 2016 revealed an average discharge time of 3 PM. A multipronged intervention was developed and carried out for this patient cohort during November 2016, aiming to improve discharge times. A physician discharge checklist was incorporated into the resident sign-out system, and a discharge planning order in the electronic medical record communicated discharge plans to floor nurses. Nurses used this information to plan and carry out required discharge at earlier times. A patient discharge checklist was also developed and distributed postoperatively to allow patients to actively engage with the discharge process.

Average Discharge Time for Urology Unit Renal Surgery Patients (N = 266)

May 2016 – November 2016 Time of Day Intervention 17:00 16:00 2:50 PM 15:00 14:00 1:52 PM 13:00 12:00 11:00 10:00 aCleveland Clinic began implementing a readmission target in 2013. 9:00 bNumber of discharges May JunJul Aug Sep Oct Nov N = 37 41 29 39 40 38 42

During the 1-month intervention period, average discharge time improved by approximately 1 hour, and discharges occurring by noon increased from 12% to 21%. The institute continues to examine the discharge process to identify additional interventions that can further improve the process.

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Percentage of Urology Unit Renal Surgery Patients Discharged by Noon

May 2016 – November 2016 Percent 25

0 Preintervention Postintervention (3 months) (1 month) N = 104 42

Reference 1. The Joint Commission. Leadership in Healthcare Organizations: A Guide to Joint Commission Leadership Standards. Published Nov. 19, 2009. jointcommission.org/leadership_in_healthcare_organizations/. Accessed Feb. 17, 2017.

2012 2013 2014 2015 393 402 464

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Surgical Site Infections Surgical site infections (SSIs) are known to increase patient morbidity and mortality, readmission rates, length of stay, and cost of healthcare delivery for patients who incur them. The Centers for Medicare & Medicaid Services (CMS) increasingly allocates payment penalties for treating complications deemed preventable, such as SSIs. The Hospital Value Based Purchasing Program uses quality data from the Hospital Inpatient Quality Reporting Program to provide financial incentive (pay for performance) to hospitals performing well in areas of quality and patient safety, and SSIs are a point of interest for these programs. Cleveland Clinic is a member of the American College of Surgeons National Surgical Quality Improvement Program® (NSQIP), an outcomes-based, data-driven, risk-adjusted surgical quality improvement program. Participation benefits include the identification of quality improvement trends, opportunities, and targets, and the ability to compare outcomes nationally to drive quality improvement in patient care. In 2013, NSQIP initiated targeted data collection for 3 urologic procedures: cystectomy (all), prostatectomy (sampled at ~ 40%), and nephrectomy (sampled at ~ 40%). After thorough cleaning, the data are analyzed and odds ratios (ORs) produced in biannual reports for each participating facility. An OR > 1 indicates that the hospital is experiencing more postoperative adverse occurrences than expected. Conversely, an OR < 1 indicates results better than expected based on patient characteristics and the complexity of the procedures performed. Urology SSI ORs revealed an opportunity to focus on improving performance and quality of care. To reduce SSIs, the institute initiated the following measures in April 2014: discussing preoperative and intraoperative antibiotic dosing and redosing during the preoperative huddle; ensuring recommended surgical preparation dry time, glove change, and wound irrigation prior to skin closure; and using a separate set of sterile closing instruments. During a 3-year period, these interventions have reduced the risk-adjusted SSI rate by almost 50%. This reduction has led to decreased morbidity and improved outcomes. Refer to page 88 for additional NSQIP performance data. Urology Surgical Site Infections: Risk-Adjusted Data

Jan. 2013 – June 2016 Odds Ratio 2.0 Benchmark 1.5

1.0

0.5

0 2013 2014 2015 7/1/15-6/30/16 No. of Events = 32 20 6 12 No. at Risk = 650 695 454 417

Source: facs.org/quality-programs/acs-nsqip

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2012 2013 2014 2015 393 402 464 Institute Quality Improvement Initiatives

Cystectomy Optimization Project The Cystectomy Optimization Project is a multidisciplinary, multimodal approach to improve the perioperative management of radical cystectomy by improving patient outcomes and reducing readmission rates, length of stay, and overall surgical management costs. Toward this goal, Cleveland Clinic has adopted an evidence-based, multidisciplinary enhanced recovery after surgery (ERAS) program. The ERAS model incorporates early patient engagement with patient centered preoperative education, minimized preoperative fasting, minimally invasive techniques, goal-directed use of intraoperative fluids, minimized opioid administration, and immediate postoperative ambulation and oral nutrition. ERAS Patient Centered Preoperative Education Preoperative patient education has been a longstanding part of the Urological & Kidney Institute approach to radical cystectomy. Despite this, there was an opportunity to improve alignment with patient expectations. A streamlined approach now includes preoperative distribution of educational packets, and tailored postoperative instruction sheets have been specifically developed for patients using short-term rehabilitation facilities. All radical cystectomy patients meet preoperatively with stoma nursing staff for operative planning and initial teaching sessions. Patients are referred to Cleveland Clinic’s Internal Medicine Preoperative Assessment, Consultant and Treatment Center for preoperative optimization and coordination of care. ERAS Perioperative Management Traditional dogma calls for fasting and bowel prep prior to radical cystectomy, and evidence for and against this practice continues to evolve. However, the institute recommends avoiding their use prior to routine cystectomy. Building evidence suggests that prolonged fasting may exacerbate underlying malnutrition and contribute to delayed wound healing and return of bowel function. The institute has adopted a protocol of fasting 6 hours prior to surgery, with clear electrolyte and carbohydrate rich fluids allowed up to 2 hours prior to surgery. Alvimopan, a μ-opioid antagonist, is administered prior to surgery. During surgery, a goal-directed fluid administration protocol is implemented to decrease overall fluid volume. Oral gastric tubes are used only during surgery, and the use of nasogastric tubes is discouraged for routine cases. Minimally invasive robot-assisted cystectomy with intracorporeal diversion is the preferred approach, resulting in decreased blood loss. Postoperatively, alvimopan administration is continued until return of bowel function and stoma teaching, discharge planning, ambulation, and a clear liquid diet are started on postoperative day 1. Postoperative narcotics are prescribed cautiously, with oral administration preferred without the routine use of patient controlled IV administration.

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Bowel Preparation, Alvimopan, and Nasogastric Tube Decline in Cystectomy Readmissions Usage and Length of Stay (N = 41)

2014 – 2016 August 2016 – December 2016 Percent Days 40 14 Yes 12 No 30 10 8 20 6 10 4 2 0 0 2014 2015 2016 Bowel Prep Alvimopan Nasogastric N = 151 127 116 Use Tube Use

Cystectomy Length of Stay (N = 41)

August 2016 – December 2016 Days 12

10 8 2012 2013 2014 2015 2012 2013 2014 2015 6 393 402 464 393 402 464 4 2 0 Intracorporeal Extracorporal Open Diversion Diversion Robotic

ERAS Postoperative Management Tailored education materials are provided at discharge, and patients are scheduled for an office or virtual visit to occur within 4 days of discharge. Dehydration is a common occurrence after cystectomy and is a frequent cause for readmission. Under the ERAS, patients are automatically scheduled with a 24-hour infusion center to treat postoperative dehydration in an outpatient setting. The infusion center is available for acute care as well as scheduled care.

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The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) objectively measures and reports risk-adjusted surgical outcomes based on a defined sampling and abstraction methodology. These outcomes data reflect Cleveland Clinic’s urology surgery ACS NSQIP performance benchmarked against 464 participating sites.

Urology Surgery Outcomes July 2015 – June 2016

Outcome N Observed Rate (%) Expected Rate (%) 30-day morbidity 419 9.31 9.91 Pneumonia 419 0.24 1.20 Renal failure 419 0.95 1.39 Urinary tract infection 418 2.39 2.75 Surgical site infection 417 2.88 3.23 Return to operating room 419 1.91 2.41 Readmission 419 8.11 8.10

In addition to overall urology ACS NSQIP outcomes data, data specific to the following procedures are provided (with the number of sites participating in benchmarking outcomes shown in parentheses): prostatectomy (76), nephrectomy (73), and cystectomy (52).

Prostatectomy Outcomes July 2015 – June 2016

Outcome N Observed Rate (%) Expected Rate (%) 30-day morbidity 167 4.19 4.51 Urinary tract infection 167 1.20 1.61 Surgical site infection 167 1.20 1.18 Sepsis 167 1.20 0.53 Readmission 167 5.39 4.16

86 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 86 8/31/17 3:14 PM Nephrectomy Outcomes July 2015 – June 2016

Outcome N Observed Rate (%) Expected Rate (%) 30-day mortality 177 0.00 0.84 30-day morbidity 177 4.52 7.70 Cardiac event 177 0.56 1.03 Pneumonia 177 0.00 1.50 Unplanned intubation 177 0.56 1.14 Ventilator > 48 hours 177 0.00 0.60 Deep vein thrombosis/pulmonary embolism 177 0.56 1.21 Renal failure 177 0.56 1.37 Urinary tract infection 176 0.00 1.63 Surgical site infection 176 1.70 1.80 Sepsis 176 2.27 0.90 C. difficile colitis 177 0.56 0.41 Return to operating room 177 1.13 1.96 Readmission 177 3.39 6.70

Cystectomy Outcomes July 2015 – June 2016

Outcome N Observed Rate (%) Expected Rate (%) 30-day morbidity 75 32.00 27.67 Cardiac event 75 1.33 1.88 Pneumonia 75 1.33 1.74 Venous thromboembolism 75 5.33 3.16 Renal failure 75 4.00 2.72 Urinary tract infection 75 10.67 7.20 Surgical site infection 74 9.46 11.69 Sepsis 75 20.00 10.32 C. difficle colitis 75 0.00 3.26 Return to operating room 75 4.00 4.52 Readmission 75 25.33 19.77 Source: facs.org/quality-programs/acs-nsqip

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Keeping patients at the center of all that Cleveland Clinic does is critical. Patients First is the guiding principle at Cleveland Clinic. Patients First is safe care, high-quality care, in the context of patient satisfaction, and high value. Ultimately, caregivers have the power to impact every touch point of a patient’s journey, including their clinical, physical, and emotional experience. Cleveland Clinic recognizes that patient experience goes well beyond patient satisfaction surveys. Nonetheless, sharing the survey results with caregivers and the public affords opportunities to improve how Cleveland Clinic delivers exceptional care.

Outpatient Office Visit Survey — Glickman Urological & Kidney Institute CG-CAHPS Assessmenta 2015 – 2016

Percent Best Response 100 2015 (N = 9594) 80 2016 (N = 9816)

60 CG-CAHPS 2015 database average (all practices)b 40

0 Appointment Doctor Doctor Rating Clerical Staff Test Results Access Communication Communication (% Always)c (% Yes, Definitely)d (% 9 or 10) (% Yes, Definitely)d (% Yes)e 0 – 10 Scale aIn 2013, Cleveland Clinic began administering the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems surveys (CG-CAHPS), standardized instruments developed by the Agency for Healthcare Research and Quality (AHRQ) and supported by the Centers for Medicare & Medicaid Services for use in the physician office setting to measure patients’ perspectives of outpatient care. bBased on results submitted to the AHRQ CG-CAHPS database from 2829 practices in 2015 cResponse options: Always, Usually, Sometimes, Never dResponse options: Yes, definitely; Yes, somewhat; No eResponse options: Yes, No Source: Press Ganey, a national hospital survey vendor

88 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 88 8/31/17 3:14 PM Inpatient Survey — Glickman Urological & Kidney Institute HCAHPS Overall Assessment 2015 – 2016 The Centers for Medicare Best Response (%) & Medicaid Services 100 requires United States 2015 (N = 887) hospitals that treat Medicare 80 2016 (N = 586) patients to participate National average in the national Hospital 60 all patientsa Consumer Assessment 40 of Healthcare Providers and Systems (HCAHPS) 20 survey, a standardized tool 0 that measures patients’ Hospital Rating Recommend Hospital perspectives of hospital b (% 9 or 10) (% Definitely Yes) care. Results collected 0 – 10 Scale for public reporting are aBased on national survey results of discharged patients, January 2015 – December 2015, from 4172 US hospitals. medicare.gov/hospitalcompare available at medicare.gov/ bResponse options: Definitely yes, Probably yes, Probably no, Definitely no hospitalcompare.

HCAHPS Domains of Carea 2015 – 2016

Best Response (%) 100 2015 (N = 887) 2016 (N = 586) b 80 National average all patients

0 Discharge Care Doctor Nurse Pain Room New Medications Responsiveness Quiet at Information Transition Communication Communication Management Clean Communication to Needs Night % Yes % Strongly % Always Agree (Options: Always, Usually, Sometimes, Never) aExcept for “Room Clean” and “Quiet at Night,” each bar represents a composite score based on responses to multiple survey questions. bBased on national survey results of discharged patients, January 2015 – December 2015, from 4172 US hospitals. medicare.gov/hospitalcompare

Source: Press Ganey, a national hospital survey vendor, 2016

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Overview Cleveland Clinic health system uses a systematic approach to performance improvement while simultaneously pursuing 3 goals: improving the patient experience of care (including quality and satisfaction), improving population health, and reducing the cost of healthcare. The following measures are examples of 2016 focus areas in pursuit of this 3-part aim. Throughout this section, “Cleveland Clinic” refers to the academic medical center or “main campus,” and those results are shown. Real-time data are leveraged in each Cleveland Clinic location to drive performance improvement. Although not an exact match to publicly reported data, more timely internal data create transparency at all organizational levels and support improved care in all clinical locations.

Improve the Patient Experience of Care Cleveland Clinic Overall Mortality Ratio Cleveland Clinic Central Line-Associated Bloodstream

2015 – 2016 Infection, reported as Standardized Infection Ratio (SIR) 2015 – 2016 O/E Ratio 1.0 Rate per 1000 Line Days 1.5 0.8 CC Performance CC target 0.6 1.0 0.4 CC Performance CC target 0.2 0.5

0.0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 0.0 2015 2016 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Source: Data from the Vizient Clinical Data Base/Resource 2015 2016 TM Manager used by permission of Vizient. All rights reserved. Cleveland Clinic has implemented several strategies to reduce central line-associated bloodstream infections Cleveland Clinic’s observed/expected (O/E) mortality ratio (CLABSIs), including a central-line bundle of insertion, outperformed its internal target derived from the Vizient maintenance, and removal best practices. Focused 2016 risk model. Ratios less than 1.0 indicate mortality reviews of every CLABSI occurrence support reductions performance “better than expected” in Vizient’s risk in CLABSI rates in the high-risk critical care population. adjustment model.

90 Outcomes 2016

108374_CCFBCH_17OUT426_acg.indd 90 8/31/17 3:14 PM Cleveland Clinic Postoperative Respiratory Failure Cleveland Clinic Hospital-Acquired Pressure Ulcer Risk-Adjusted Rate Prevalence (Adult)

2015 – 2016 2015 – 2016

Rate per 1000 Eligible Patients Percent 10 3 CC Performance CC target 8 2 6

4 1 CC Performance 2 NDNQI 50th (Academic Medical Centers) 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2015 2016 2015 2016

Source: Data from the Vizient Clinical Data Base/Resource Source: Data reported from the National Database for Nursing Quality ManagerTM used by permission of Vizient. All rights reserved. Indicators® (NDNQI®) with permission from Press Ganey. Efforts continue toward reducing intubation time, A pressure ulcer is an injury to the skin that can be caused assessing readiness for extubation, and preventing the by pressure, moisture, or friction. These sometimes occur need for reintubation. Cleveland Clinic has leveraged when patients have difficulty changing position on their the technology within the electronic medical record own. Cleveland Clinic caregivers have been trained to to support ongoing improvement efforts in reducing provide appropriate skin care and regular repositioning postoperative respiratory failure (AHRQ Patient Safety while taking advantage of special devices and mattresses Indicator 11). Prevention of respiratory failure remains a to reduce pressure for high-risk patients. In addition, they safety priority for Cleveland Clinic. actively look for hospital-acquired pressure ulcers and treat them quickly if they occur. Cleveland Clinic strategies to mitigate the risk of these pressure injuries include routine rounding to accurately stage pressure injuries, monthly multidisciplinary wound care meetings, and ongoing nursing education, both in the classroom and at the bedside.

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Keeping patients at the center of all that we do is critical. We know that patient experience goes well beyond Inpatient Survey — Cleveland Clinic Patients First is the guiding principle at Cleveland Clinic. patient satisfaction surveys. Nonetheless, by sharing the HCAHPS Overall Assessment Patients First is safe care, high-quality care, in the context survey results with our caregivers and the public, we 2015 – 2016 of patient satisfaction, and high value. Ultimately, our constantly identify opportunities to improve how we deliver Best Response (%) caregivers have the power to impact every touch point of exceptional care. 100 The Centers for Medicare a patient’s journey, including their clinical, physical, and 2015 (N = 10,007) & Medicaid Services emotional experience. 80 2016 (N = 9972)a requires United States National average hospitals that treat Medicare 60 all patientsb patients to participate Outpatient Office Visit Survey — Cleveland Clinic in the national Hospital a 40 CG-CAHPS Assessment Consumer Assessment 2015 – 2016 20 of Healthcare Providers and Systems (HCAHPS) 2015 (N = 225,905) CG-CAHPS 2015 database average 0 Best Response (%) b 2016 (N = 254,179) (all practices) Hospital Rating Recommend Hospital survey, a standardized tool 100 (% 9 or 10) (% Definitely Yes)c that measures patients’ 0 – 10 Scale perspectives of hospital 80 aAt the time of publication, 2016 ratings have not been reported by the Centers for care. Results collected Medicare & Medicaid Services and ratings are not adjusted for patient mix. 60 bBased on national survey results of discharged patients, January 2015 – December 2015, for public reporting are from 4172 US hospitals. medicare.gov/hospitalcompare available at medicare.gov/ c 40 Response options: Definitely yes, Probably yes, Probably no, Definitely no hospitalcompare. 20 HCAHPS Domains of Carea 2015 – 2016 0 Appointment Specialty Care Primary Care Doctor Rating Clerical Staff Test Results Best Response (%) 2015 (N = 10,007) Access Doctor Communication Communication 100 2016 (N = 9272)b c d c d e (% Always) (% Yes, Definitely) (% Always) (% 9 or 10) (% Yes, Definitely) (% Yes) National average all patientsc 0 – 10 Scale 80 aIn 2013, Cleveland Clinic began administering the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems surveys (CG-CAHPS), standardized instruments developed by the Agency for Healthcare Research and Quality (AHRQ) and supported by the Centers for Medicare & Medicaid Services for 60 use in the physician office setting to measure patients’ perspectives of outpatient care. bBased on results submitted to the AHRQ CG-CAHPS database from 2829 practices in 2015 40 cResponse options: Always, Usually, Sometimes, Never d Response options: Yes, definitely; Yes, somewhat; No 20 eResponse options: Yes, No Source: Press Ganey, a national hospital survey vendor 0 Discharge Care Doctor Nurse Pain Room New Medications Responsiveness Quiet at Information Transition Communication Communication Management Clean Communication to Needs Night % Yes % Strongly % Always Agree (Options: Always, Usually, Sometimes, Never) aExcept for “Room Clean” and “Quiet at Night,” each bar represents a composite score based on responses to multiple survey questions. bAt the time of publication, 2016 ratings have not been reported by the Centers for Medicare & Medicaid Services and ratings are not adjusted for patient mix. cBased on national survey results of discharged patients, January 2015 – December 2015, from 4172 US hospitals. medicare.gov/hospitalcompare

Source: Centers for Medicare & Medicaid Services, 2015; Press Ganey, a national hospital survey vendor, 2016

922 Outcomes 2016 Orthopaedic & Rheumatologic Institute 3

108374_CCFBCH_17OUT426_acg.indd 92 8/31/17 3:14 PM Inpatient Survey — Cleveland Clinic HCAHPS Overall Assessment 2015 – 2016 Best Response (%) 100 The Centers for Medicare 2015 (N = 10,007) & Medicaid Services 80 2016 (N = 9272)a requires United States National average hospitals that treat Medicare 60 all patientsb patients to participate 40 in the national Hospital Consumer Assessment 20 of Healthcare Providers and Systems (HCAHPS) 0 Hospital Rating Recommend Hospital survey, a standardized tool (% 9 or 10) (% Definitely Yes)c that measures patients’ 0 – 10 Scale perspectives of hospital aAt the time of publication, 2016 ratings have not been reported by the Centers for care. Results collected Medicare & Medicaid Services and ratings are not adjusted for patient mix. bBased on national survey results of discharged patients, January 2015 – December 2015, for public reporting are from 4172 US hospitals. medicare.gov/hospitalcompare available at medicare.gov/ c Response options: Definitely yes, Probably yes, Probably no, Definitely no hospitalcompare. HCAHPS Domains of Carea 2015 – 2016 Best Response (%) 2015 (N = 10,007) 100 2016 (N = 9272)b National average all patientsc 80

0 Discharge Care Doctor Nurse Pain Room New Medications Responsiveness Quiet at Information Transition Communication Communication Management Clean Communication to Needs Night % Yes % Strongly % Always Agree (Options: Always, Usually, Sometimes, Never) aExcept for “Room Clean” and “Quiet at Night,” each bar represents a composite score based on responses to multiple survey questions. bAt the time of publication, 2016 ratings have not been reported by the Centers for Medicare & Medicaid Services and ratings are not adjusted for patient mix. cBased on national survey results of discharged patients, January 2015 – December 2015, from 4172 US hospitals. medicare.gov/hospitalcompare

Source: Centers for Medicare & Medicaid Services, 2015; Press Ganey, a national hospital survey vendor, 2016

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Focus on Value

Cleveland Clinic has developed and implemented new models of care that focus on “Patients First” and aim to deliver on the Institute of Medicine goal of Safe, Timely, Effective, Efficient, Equitable, Patient-centered care. Creating new models of Value-Based Care is a strategic priority for Cleveland Clinic. As care delivery shifts from fee-for-service to a population health and bundled payment delivery system, Cleveland Clinic is focused on concurrently improving patient safety, outcomes, and experience. What does this new model of care look like?

Integrated Care Model

Retail Venues Home

Community-Based Care System Organizations Outpatient Clinics

Post-acute Emergency (other)

Ambulatory Independent MyChart Physician Diagnosis & Treatment Offices

Hospitals Skilled Nursing Facilities Rehabilitation Facilities

The Cleveland Clinic Integrated Care Model (CCICM) is a value-based model of care, designed to improve outcomes while reducing cost. It is designed to deliver value in both population health and specialty care. • The patient remains at the heart of the CCICM. • The blue band represents the care system, which is a seamless pathway that patients move along as they receive care in different settings. The care system represents integration of care across the continuum. • Critical competencies are required to build this new care system. Cleveland Clinic is creating disease- and condition-specific care paths for a variety of procedures and chronic diseases. Another facet is implementing comprehensive care coordination for high-risk patients to prevent unnecessary hospitalizations and emergency department visits. Efforts include managing transitions in care, optimizing access and flow for patients through the CCICM, and developing novel tactics to engage patients and caregivers in this work. • Measuring performance around quality, safety, utilization, cost, appropriateness of care, and patient and caregiver experience is an essential component of this work.

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Cleveland Clinic Accountable Care Organization Measure Performance

2016

National Percentile Ranking

• Falls Screening • Heart Failure 90th • Ischemic Vascular Disease • BMI Screening • Tobacco Screening

• Coronary Artery Disease • Diabetes 80th • Breast Cancer Screening • Pneumonia Vaccination

• Colorectal Cancer Screening • Influenza Vaccination 70th • Blood Pressure Screening • Hypertension

50th • Depression Screening

Higher percentiles are better

As part of Cleveland Clinic’s commitment to population health and in support of its Accountable Care Organization (ACO), these ACO measures have been prioritized for monitoring and improvement. Cleveland Clinic is improving performance in these measures by enhancing care coordination, optimizing technology and information systems, and engaging primary care specialty teams directly in the improvement work. These pursuits are part of Cleveland Clinic’s overall strategy to transform care in order to improve health and make care more affordable.

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Reduce the Cost of Care

Cleveland Clinic All-Cause 30-Day Readmission Rate to Any Cleveland Clinic Hospital

2015 – 2016

Percent Readmission Rate Case Mix Index 18 3 16 14 12 2 10 8 CC Rate 6 1 CC CMI 4 Vizient AAMC CMI 2 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2015 2016

Cleveland Clinic monitors 30-day readmission rates for any reason to any of its system hospitals. Unplanned readmissions are actively reviewed for improvement opportunities. Comprehensive care coordination and care management for high-risk patients has been initiated in an effort to prevent unnecessary hospitalizations and emergency department visits. Sicker, more complex patients are more susceptible to readmission. Case mix index (CMI) reflects patient severity of illness and resource utilization. Cleveland Clinic’s CMI remains one of the highest among American academic medical centers.

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Additional 10,500 in control 131 fewer strokes 100 fewer heart attacks 75 fewer early deaths 74%

68%

2010 2011 2012 2013 2014 2015 2016

Cleveland Clinic was one of the top performing new ACOs in the United States (for 2015 performance as determined in 2016) due to efficiency, cost reduction, and improvements in effectiveness of chronic disease management such as treating hypertension, reducing preventable hospitalizations through care coordination, and optimizing the care at skilled nursing facilities through its Connected Care program. For example, a system-wide effort to improve the control of blood pressure for patients with hypertension was begun in 2016 and resulted in an additional 10,500 patients with blood pressure controlled. This will translate to many fewer strokes, heart attacks, and preventable deaths.

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A Nomogram for Predicting Ureteral Stone Passage Will my stone pass? This is the question paramount P = 0.451) and stone passage. In the multivariable model, in patients’ minds after renal colic subsides. Glickman stone size (per 1 mm increase; OR 0.49; Urological & Kidney Institute researchers developed a 95% CI 0.43-0.57; P < 0.001), stone location nomogram based on a review of 1146 patients, using (P < 0.0001), prior history of stone passage variables chosen for clinical and statistical significance that (OR 1.74; 95% CI, 1.04-2.93; P = 0.036), and white were validated internally with a bootstrapping technique. blood cell count (per 1000/µL increase; OR 1.12; 95% A review was conducted of emergency department visits CI, 1.04-1.21; P = 0.001) were significantly associated within the health system that had an ICD-9 diagnosis of with spontaneous stone passage. The model was validated urolithiasis, an associated CT scan, and a discharge with internally (bootstrap-adjusted concordance index, 0.80) and medical expulsive therapy from 2010–2013. On univariable demonstrated excellent calibration. analysis, patients who passed stones tended to have smaller For emergency department patients presenting with ureteral stones (3.6 mm vs 5.2 mm, P < 0.001), stones in the stones amenable to observation, this nomogram can distal ureter (73% vs 41%, P < 0.001), and significantly guide early follow-up or intervention for those with a low higher white blood cell counts (9.49 vs 8.57, P < 0.001). probability of stone passage, improving patient satisfaction There were no associations between age (49 years vs 50 and preventing costly emergency department returns. years, P = 0.831) or gender (among males: 64% vs 62%

Nomogram for Predicting the Probability of Stone Passage

01020 30 40 50 60 70 80 90 100 Points

Size of ureteral stone 16 14 12 10 8 6 4 2 0 Middle Stone location Proximal 1 Prior passage 0 White blood cell count 2 8 14 20 Total points 0102030405060708090 100 120 Probability of stone passage 0.1 0.2 0.4 0.6 0.8 0.9

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108374_CCFBCH_17OUT426_acg.indd 98 8/31/17 3:14 PM Robotic-Assisted Salvage Pyeloplasty With Buccal Mucosal Onlay Graft The surgical management of recurrent ureteropelvic junction (UPJ) obstruction is challenging, with a high rate of recurrence leading to progressively complex repairs. Glickman Urological & Kidney Institute surgeons have used a buccal mucosal graft (BMG) in a salvage robotic laparoscopic pyeloplasty for managing recurrent UPJ obstruction in 2 adults, both of whom had failed at least 2 prior pyeloplasties and subsequent endoscopic management. During the procedure, the UPJ and ureter are exposed, the stricture is incised and spatulated into healthy tissue on both ends, and a BMG is harvested and placed as an anterior onlay to augment the strictured segment. Short term outcomes are promising and without complications. Early results suggest that this approach can provide a tension-free repair with minimal mobilization of the kidney, renal pelvis, and ureter, even in cases with significant fibrosis. This technique is an attractive alternative in the management of recurrent UPJ obstruction and may help obviate the need for more invasive surgical repair.

Buccal mucosa onlay graft sutured into place, bridging the UPJ and augmenting the stricture

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Bulbar Urethral Stent Clinical Utility of Novel Oxidation-Reduction Potential 1 Institute urologists invented the bulbar urethral stent, a Assay in Male Factor Infertility novel device made of 2 silicone tubes with one inside Institute researchers have established an oxidation- the other that are placed in the bulbar urethra with an reduction potential assay (ORP) using a novel galvanostatic anchoring device. The stent has 2 strings that exit the technology as an effective method for measuring oxidative urethral meatus and is designed so that pulling one string stress in semen and distinguishing normal men from male will advance the inner tube through the prostatic urethra factor infertility patients. ORP captures a reliable, complete, to enter the bladder and drain it. Pulling the other string and rapid picture of oxidative stress in a given semen will retract the inner tube back to its original position in the sample, providing a functional component not contained bulbar urethra. within the semen analysis. Identification of abnormal levels Unlike other temporary prosthetic stents, the bulbar of oxidative stress can enhance clinical understanding urethral stent has no balloon in the bladder and no tube related to poor sperm function, especially in idiopathic in the prostatic urethra and is indicated for the treatment and unexplained male infertility cases, and help optimize of urinary retention due to benign prostatic hyperplasia treatment strategies for male factor infertility. with obstruction as well as urinary retention due to atonic neurogenic and nonneurogenic bladder. A B

Galvanostatic assay system components: analyzer (A) and sensor (B)

Reference 1. Agarwal A, Sharma R, Roychoudhury S, Du Plessis S, Sabanegh E. MiOXSYS: a novel method of measuring oxidation reduction potential in semen and seminal plasma. Fertil Steril. 2016 Sep 1;106(3):566-573.e.10. Bulbar urethral stent with tube inserted and retracted

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108374_CCFBCH_17OUT426_acg.indd 100 8/31/17 3:14 PM Radioactive vs Nonradioactive Iothalamate in GFR Measurement Assessment of kidney function is best reflected by Correlation Coefficient of the Measurement Methods the glomerular filtration rate (GFR). Radioactive October 2011 – January 2013 iothalamate is commonly used as a tracer for GFR measurement, but the handling of radioactive Hot lothalamate (mL/min/1.73m2) material is cumbersome and challenging for many 150 institutions. Institute researchers compared GFR Regression Analysis (95% CI) measurements using radioactive iothalamate 1:1 lower case line (measured by gamma counting) and nonradioactive iothalamate (measured by liquid chromatography- tandem mass spectrometry). 100 Patients received simultaneous subcutaneous injections of 125I sodium iothalamate and iothalamate meglumine 60%. A total of 36 patients were enrolled between October 2011 and January 2013; 18 were males (50%). Mean age was 50.9 ± 15.8 years. GFR measurement 50 ranges were 1.67–125.33 mL/min with a mean of 62.874 ± 38.427 mL/min for the radioactive iothalamate and 1.45–122.96 mL/min with a mean of 61.073 ± 37.852 mL/min for the nonradioactive iothalamate. 0 The correlation coefficient of the 2 measurement 0501100 50 methods was 0.99 with a bias of -1.81 (-2.9%). Cold lothalamate (mL/min/1.73m2) The study shows an excellent correlation between Deming Regression Analysis renal clearances of radioactive and nonradioactive iothalamate. In addition to being radiation free, Slope (95% CI) 0.985 (0.942 to 1.028) this method is practical and avoids the need for a Intercept (95% CI) -0.854 (-4.023 to 2.315) 24-hour urine collection. Standard Error Estimate 4.755

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Urology Appointments/Referrals Staff Listing 216.444.5600 or 800.223.2273, ext. 45600 For a complete listing of Cleveland Clinic’s Glickman Urological & Kidney Institute staff, please visit Nephrology Appointments/Referrals clevelandclinic.org/staff. 216.444.6771 or 800.223.2273, ext. 46771 Publications Glickman Urological & Kidney On the Web at Institute staff authored 172 clevelandclinic.org/glickman publications in 2016 as indexed within Web of Science.

Locations For a complete listing of Glickman Urological & Kidney Institute locations, please visit clevelandclinic.org/glickman.

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108374_CCFBCH_17OUT426_acg.indd 102 8/31/17 3:14 PM Additional Contact Information Global Patient Services/ International Center General Patient Referral Complimentary assistance for international 24/7 hospital transfers or physician patients and families consults 001.216.444.8184 or visit 800.553.5056 clevelandclinic.org/gps

General Information Medical Concierge 216.444.2200 Complimentary assistance for out-of-state patients and families Hospital Patient Information 800.223.2273, ext. 55580, or 216.444.2000 email [email protected]

General Patient Appointments Cleveland Clinic Abu Dhabi 216.444.2273 or 800.223.2273 clevelandclinicabudhabi.ae

Referring Physician Center and Hotline Cleveland Clinic Canada 855.REFER.123 (855.733.3712) 888.507.6885 Or email [email protected] or visit clevelandclinic.org/refer123 Cleveland Clinic Florida 866.293.7866 Request for Medical Records 216.444.2640 or Cleveland Clinic Nevada 800.223.2273, ext. 42640 702.796.8669

Same-Day Appointments For address corrections or changes, 216.444.CARE (2273) please call 800.890.2467

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Overview The Cleveland Clinic Model Cleveland Clinic is an academic medical center Cleveland Clinic was founded in 1921 by 4 physicians offering patient care services supported by research who had served in World War I and hoped to replicate and education in a nonprofit group practice setting. the organizational efficiency of military medicine. The More than 3500 Cleveland Clinic staff physicians and organization has grown through the years by adhering to the scientists in 140 medical specialties and subspecialties nonprofit, multispecialty group practice they established. care for more than 7.1 million patients across the system All Cleveland Clinic staff physicians receive a straight salary annually, performing nearly 208,000 surgeries and with no bonuses or other financial incentives. The hospital conducting more than 652,000 emergency department and physicians share a financial interest in controlling costs, visits. Patients come to Cleveland Clinic from all 50 and profits are reinvested in research and education. states and 185 nations. Cleveland Clinic’s CMS case-mix Cleveland Clinic Florida was established in 1987. Cleveland index is the second-highest in the nation. Clinic began opening family health centers in surrounding Cleveland Clinic is an integrated healthcare delivery communities in the 1990s. Marymount Hospital joined system with local, national, and international reach. Cleveland Clinic in 1995, followed by regional hospitals The main campus in midtown Cleveland, Ohio, has including Euclid Hospital, Fairview Hospital, Hillcrest a 1400-bed hospital, outpatient clinic, specialty Hospital, Lutheran Hospital, Medina Hospital, South Pointe institutes, labs, classrooms, and research facilities in Hospital, and affiliate Ashtabula County Medical Center. 44 buildings on 167 acres. Cleveland Clinic has more In 2015, the Akron General Health System joined the than 150 northern Ohio outpatient locations, including Cleveland Clinic health system. 10 regional hospitals, 18 full-service family health Internally, Cleveland Clinic services are organized into centers, 3 health and wellness centers, an affiliate patient-centered integrated practice units called institutes, hospital, and a rehabilitation hospital for children. each institute combining medical and surgical care for Cleveland Clinic also includes Cleveland Clinic Florida; a specific disease or body system. Cleveland Clinic was Cleveland Clinic Nevada; Cleveland Clinic Canada; among the first academic medical centers to establish an Cleveland Clinic Abu Dhabi, UAE; Sheikh Khalifa Office of Patient Experience, to promote comfort, courtesy, Medical City (management contract), UAE; and and empathy across all patient care services. Cleveland Clinic London (opening in 2020). Cleveland Clinic is the largest employer in Ohio, with more than A Clinically Integrated Network 51,000 employees. It generates $12.6 billion of Cleveland Clinic is committed to providing value-based care, economic activity a year. and it has grown the Cleveland Clinic Quality Alliance into Cleveland Clinic supports physician education, training, the nation’s second-largest, and northeast Ohio’s largest, consulting, and patient services around the world clinically integrated network. The network comprises more through representatives in the Dominican Republic, than 6300 physician members, including both Cleveland Guatemala, India, Panama, Peru, Saudi Arabia, and the Clinic staff and independent physicians from the community. United Arab Emirates. Dedicated Global Patient Services Led by its physician members, the Quality Alliance strives to offices are located at Cleveland Clinic’s main campus, improve quality and consistency of care; reduce costs and Cleveland Clinic Abu Dhabi, Cleveland Clinic Canada, increase efficiency; and provide access to expertise, data, and Cleveland Clinic Florida. and experience.

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108374_CCFBCH_17OUT426_acg.indd 104 8/31/17 3:14 PM Cleveland Clinic Lerner College of Medicine

Lerner College of Medicine is known for its small class sizes, unique curriculum, and full-tuition scholarships for all students. Each new class accepts 32 students who are preparing to be physician investigators. In 2015, Cleveland Clinic broke ground on a 477,000-square-foot multidisciplinary Health Education Campus. The campus, which will open in July 2019, will serve as the new home of the Case Western Reserve University (CWRU) School of Medicine and Cleveland Clinic’s Lerner College of Medicine, as well as the CWRU School of Dental Medicine, the Frances Payne Bolton School of Nursing, and physician assistant and allied health training programs.

Graduate Medical Education

In 2016, nearly 2000 residents and fellows trained at Cleveland Clinic and Cleveland Clinic Florida in our continually growing programs.

U.S. News & World Report Ranking

Cleveland Clinic is ranked the No. 2 hospital in America by U.S. News & World Report (2016). It has ranked No. 1 in heart care and heart surgery since 1995. In 2016, 3 of its programs were ranked No. 2 in the nation: gastroenterology and GI surgery, nephrology, and urology. Ranked among the nation’s top five were gynecology, orthopaedics, rheumatology, pulmonology, and diabetes and endocrinology.

Cleveland Clinic Physician Ratings

Cleveland Clinic believes in transparency and in the positive influence of the physician-patient relationship on healthcare outcomes. To continue to meet the highest standards of patient satisfaction, Cleveland Clinic physician ratings, based on nationally recognized Press Ganey patient satisfaction surveys, are published online at clevelandclinic.org/staff.

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Referring Physician Center and Hotline Medical Records Online Call us 24/7 for access to medical services or to Patients can view portions of their medical record, receive schedule patient appointments at 855.REFER.123 diagnostic images and test results, make appointments, and (855.733.3712), email [email protected], or go to renew prescriptions through MyChart, a secure online portal. clevelandclinic.org/Refer123. The free Cleveland Clinic All new Cleveland Clinic patients are automatically registered Physician Referral App, available for mobile devices, for MyChart. clevelandclinic.org/mychart gives you 1-click access. Available in the App Store or Google Play. Access

Remote Consults Cleveland Clinic is committed to convenient access, offering virtual visits, shared medical appointments, and walk-in Anybody anywhere can get an online second opinion urgent care for your patients. clevelandclinic.org/access from a Cleveland Clinic specialist through our MyConsult service. For more information, go to clevelandclinic.org/myconsult, email [email protected], Critical Care Transport Worldwide or call 800.223.2273, ext. 43223. Cleveland Clinic’s fleet of ground and air transport vehicles

is ready to transfer patients at any level of acuity anywhere Request Medical Records on Earth. Specially trained crews provide Cleveland Clinic 216.444.2640 or 800.223.2273, ext. 42640 care protocols from first contact. To arrange a transfer for STEMI (ST-elevation myocardial infarction), acute stroke, ICH Track Your Patients’ Care Online (intracerebral hemorrhage), SAH (subarachnoid hemorrhage), or aortic syndrome, call 877.379.CODE (2633). For all other Cleveland Clinic offers an array of secure online services critical care transfers, call 216.444.8302 or 800.553.5056. that allow referring physicians to monitor their patients’

treatment while under Cleveland Clinic care and gives them access to test results, medications, and treatment CME Opportunities: Live and Online plans. my.clevelandclinic.org/online-services Cleveland Clinic’s Center for Continuing Education operates DrConnect (online access to patients’ treatment progress the largest CME program in the country. Live courses are while under referred care): call 877.224.7367, email offered in Cleveland and cities around the nation and the [email protected], or visit clevelandclinic.org/drconnect. world. The center’s website (ccfcme.org) is an educational resource for healthcare providers and the public. It has a MyPractice Community (affordable electronic medical calendar of upcoming courses, online programs on topics records system for physicians in private practice): in 30 areas, and the award-winning virtual textbook of 216.448.4617. medicine, The Disease Management Project. eRadiology (teleradiology consultation provided nationwide by board-certified radiologists with specialty training, within 24 hours or stat): call 216.986.2915 or email [email protected].

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108374_CCFBCH_17OUT426_acg.indd 106 8/31/17 3:14 PM Measuring Outcomes Promotes Quality Improvement

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Graphic design and photography were provided by Cleveland Clinic’s Center for Medical Art and Photography.

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